Requirements for Physico-Technical Quality Assurance in the Framework of Early Detection of Lung Cancer

Abstract

Summary

According to the text of the Lung Cancer Screening Ordinance on the permissibility of using low-dose computed tomography to screen smokers (LuKrFrühErkV, §7 Quality Assurance, [1]), the “radiation protection officer must establish and operate a comprehensive quality assurance system. This must take account of organizational, medical, and technical aspects, in particular [...] 2. the diagnostic image quality of the computed tomography scan, 3. the physical-technical parameters for the acquisition of the computed tomography scan [...]”.
The German Radiological Society (DRG) considers itself responsible for making recommendations regarding the implementation of such a quality assurance system, in order to provide users with legal certainty and ensure patient safety.
The DRG’s Physics and Technology Working Group has thus identified the main issues regarding quality assurance for technology, outlined the related challenges, and proposed potential areas for future investigation and resolution (see sections I–V).
Existing quality assurance measures for technology must be checked for their suitability with regard to a low-dose screening program and adapted, if necessary.
Complex additional constancy tests and the use of special (anthropomorphic) phantoms are not currently considered necessary. The tasks of manufacturers and medical physicists were refined further, and it was recommended that reference centers should be established as soon as possible.

Key Points

• Constancy testing methods for CT are largely sufficient for lung cancer screening.

• Daily air calibration is recommended to ensure consistent image quality.

• Anthropomorphic phantoms are not currently required for quality assurance.

• Manufacturers must provide protocols that meet LuKrFrühErkV requirements.

Citation Format

Eßeling R, Konrad M, Prokesch H et al. Requirements for Physico-Technical Quality Assurance in the Framework of Early Detection of Lung Cancer. Rofo 2026; DOI 10.1055/a-2597-0689

Keywords

CT - QA/QC - screening - quality assurance - lung cancer screening - constancy test

Status quo of lung cancer screening

With the Lung Cancer Screening Ordinance (LuKrFrühErkV) [1] and the decision by the Federal Joint Committee (G-BA) of June 18, 2025 [2], lung cancer screening is now approved as a new service covered by Germany’s statutory health insurance funds. Starting in April 2026, lung cancer screening in Germany is expected to begin on a large scale. For this reason, it is absolutely essential to establish quality assurance measures.

Currently, the scope of physico-technical quality assurance for CT devices in radiology is mostly limited to the acceptance and constancy tests formally required by DIN EN IEC 61223–3-5 [3]. This scope is perfectly adequate for the primary purpose for which the devices are used, i.e. clinical diagnostics. However, when conducting quantitative evaluations of low-dose studies (especially to determine the volume doubling time), it is important to re-evaluate the permissible tolerance ranges for the variability of the technical parameters. This position paper addresses when and in what form additional quality assurance should be conducted for low-dose CT protocols.

In Germany, a broad spectrum of devices and software versions are used in lung cancer screening. The influence of arbitrary, non-standardized examination protocols on volume determination for pulmonary nodules and the growth rate determined for lung cancer tumors is the subject of long-standing and ongoing discussion [4]. The variability of a multitude of factors and the complex parameter range, including the device used, radiation exposure, slice thickness, type of reconstruction algorithm and kernel, object properties (e.g. size, shape, location), respiration process, and software, can significantly influence the measured values [5] [6] [7] [8].

As a result, manufacturers are required to provide their users with corresponding recommendations in order to minimize variability as far as possible when selecting the right parameters for CT acquisition protocols. These recommendations should follow the appendix to Sec. 4 Para. 1 Sentence 1 of LuKrFrühErkV and the clarifications set forth in this paper (see Appendix). There are currently no European guidelines for the range of options for protocol parameters and the resulting differences in image quality for the various device types. In other words, physico-technical quality assurance in lung cancer screening has yet to be implemented [9].

The Physics and Technology Working Group of the German Radiological Society has therefore addressed this pressing issue and formulated relevant recommendations for physico-technical quality assurance (see the info box) in line with the position paper by Hahn et al. on requirements for quality assurance of AI models for early detection of lung cancer [10].

For information on the abbreviations used here, refer to List of abbreviations.

Literature review and current challenges for physico-technical quality assurance in lung cancer screening

Currently, no empirical data is available regarding variability or stability/linearity in the low-dose range for CT. Constancy tests are performed with a significantly higher dose compared to a suitable screening protocol and are therefore not representative.

With regard to reproducibility of exposure for CT scans with a CTDI_vol value in the 1 mGy range, the authors are unaware of any publication that considers inter- or intra-device dependent dosimetric variability.

Years of experience have led to a high level of confidence in the stability and reproducibility of dose and image quality, and the testing intervals have therefore recently been extended [11] [12].

Despite the increasing implementation of lung cancer screening programs, a significant information gap remains regarding physico-technical quality assurance. Konrad et al. address this issue and the authors highlight the need for a systematic survey and standardization of CT acquisition protocols currently in use, in order to ensure the quality and sustainability of screening over the long term [13].

In the UK, a CT protocol was established as part of a screening study, which was adapted explicitly in line with the recommendations of the Quantitative Imaging Biomarkers Alliance (QIBA). Lung-specific phantoms were used in the study to objectively verify image quality and calculate doses [14]. The protocol established by Iball et al. is largely based on the QIBA Small Lung Nodule (SLN) Profile. The publication emphasizes the need to implement quality assurance in the detection and monitoring of pulmonary nodules when using quantitative imaging [15].

In its technical recommendations for lung cancer screening, the European Society of Thoracic Imaging (ESTI) sets forth detailed requirements for CT acquisition and image reconstruction [16]. However, quality assurance is not addressed here. For applications in Germany, the recommendations only provide European comparative values. However, these have to be adapted considerably in practice to ensure regulatory compliance with specific national laws and the LuKrFrühErkV.

The American Association of Physicians in Medicine (AAPM) has published device-specific protocol recommendations for lung cancer screening [17]. There is no explicit reference to physico-technical quality assurance in terms of European or German requirements.

The systematic review by Guedes Pinto et al. clearly demonstrates that the data on the factors influencing the volumetry of pulmonary nodules is currently insufficient. In particular, the clinical relevance of many study results cannot yet be fully assessed [7].

While the influence of evaluation software and algorithms on volume determination for pulmonary nodules undoubtedly plays an important role in the overall sensitivity and specificity of lung cancer screening, this position paper focuses specifically on the physico-technical aspects of quality assurance for CT imaging. The evaluation software used may also impose further requirements on the parameters for the technological implementation and must itself be subject to quality assurance. This cannot currently be evaluated further without a structured lung cancer screening program. Particularly for small tumors, there can be significant differences in volumetric assessment [18]. For a comprehensive analysis of the challenges and standards in the field of evaluation software, readers should refer to the current overview by Hahn et al. [10], which deals with this aspect in detail.

In addition to the studies mentioned, the review by Vonder et al. provides a well-organized overview of the international literature on CT acquisition protocols in lung cancer screening, and it underscores the need for further standardization [19].

I. Are previous acceptance and constancy tests applicable for the low-dose range (especially CT series with CTDI_vol ≤ 1.3 mGy)?

Quality assurance for technology according to previous DIN standards:

The established acceptance and constancy tests based on the DIN EN IEC 61223–3-5 standard [3] are currently considered sufficient for the early detection of lung cancer [20] [21]. However, these should be re-evaluated continually, building on the findings obtained scientifically by monitoring screenings (see Section VI).

According to a report from the Federal Office for Radiation Protection (BfS) (BfS-34/21, 2021, point 3.9.1.1 [22]), it is particularly important to provide technical quality assurance for the equipment, devices, and appliances. This includes verifying the physico-technical parameters through acceptance, constancy, and expert tests with regard to the quality objective in Sec. 14 Para. 1 Sentence 5a of StrlSchG.

The constancy test for the dose must be conducted annually as well as after a major maintenance or repair activity (e.g. replacing a tube or detector, etc.).

After consultation with the manufacturers of CT equipment who are members of ZVEI, or the Central Association of the Electrical and Electronics Industry, it is assumed that the CTDI_vol dose value of 1.3 mGy is maintained, with regard to the expected accuracy based on the standard above [3]. This is confirmed accordingly by the manufacturers in the accompanying documents.

According to point 5.4.6.1 of the standard [3], a deviation of the CTDI_vol of ± 20% is tolerated. The second tolerance criterion in the standard of ±1 mGy for the CTDI_vol value is not, however, applicable, as such a high deviation is unacceptable at the current low dose level.

II. What should an additional constancy test for a lung cancer screening CT protocol include?

Expanding the annual constancy test (after adapting the protocol)

The test parameters used in the current DIN EN IEC 61223–3-5 standard only provide for dose measurement, under typical operating conditions, of an adultʼs body and head, or a child’s body and head. The measured dose values are typically 20 mGy and higher. Therefore, the results are not representative for the low-dose range. Nevertheless, manufacturers guarantee that the dose displayed is within a tolerance of approximately ±20% (with higher pre-filtration, e.g. with tin or silver, discrepancies of up to ± 30% are possible).

The recommended protocols for lung cancer screening are no exception. Taking into account the reasons cited above, the Physics and Technology Working Group considers it useful to monitor the CTDI_vol value of the screening protocols used in the annual constancy test.

Daily quality assurance measures:

Although this is a high-contrast issue, which is often considered less critical in terms of image quality, the extent to which the low dose and the resulting higher noise can lead to uncertainties in volume determination remains unclear. Specifically, modern CT devices are highly sensitive, which can result in ring artifacts in low-dose scans. This can occur when detector units are not properly calibrated to each other or when the calibration is outdated [23]. To reduce the number of artifacts, daily air calibration is recommended, in order to ensure consistent image quality in terms of uniformity and freedom from errors.

Quality assurance using anthropomorphic phantoms

Current studies dealing with quality assurance in lung cancer screening point primarily to problems related to the scan protocol or the procedure itself. The working group of Rydzak et al. identifies avoidable technological problems. These include, among other things, a faulty FOV, patient movement, or stripe, ring, and noise artifacts in the image. Rydzak et al. therefore recommend complying with the relevant national regulations and the manufacturer’s guidelines, maintenance, and routine tests to ensure sufficient image quality for lung cancer screening. The use of anthropomorphic phantoms is not considered necessary [9]. Gierada et al. also point to reductions in image quality in CT lung cancer screening caused by faulty scan parameters. No recommendation is made for quality assurance using anthropomorphic phantoms [24]. Already in 2015, sufficient sensitivity for the automatic detection of nodules >12 mm was demonstrated for low-dose CT [25]. For artificially created lesions with a diameter of 5 mm, the error in volume determination for scans with 1.54 mGy was less than 30%, even for soft tissue kernels [8].

If this preliminary assessment changes during the screening evaluation, either existing commercial solutions can be used or newly developed anthropomorphic phantoms can be employed. In the event of such a reassessment, recommendations will be made regarding the phantom (design, material, etc.). A good example of this is the work of Hernandez-Giron et al., which demonstrated that 3D-printed lung phantoms can generate clinically relevant and reproducible readings in CT [26].

Existing quality assurance measures for technology must be reviewed for their suitability for low-dose screening programs. This includes, in particular, the regular determination of dosage-related uncertainties such as CTDI_vol deviations (especially after hardware update/maintenance), as well as suitability testing for the filter kernels and reconstruction algorithms used in the screening protocols (especially after software updates), since these affect resolution and volumetry.

III. What tasks should device manufacturers take on?

Recommendations for scan parameters

Manufacturers should provide the following information for their users:

1. An overview of suitable protocols for lung cancer screening.

2. Instructions explaining how to adapt existing protocols in line with the specifications in the appendix, taking into account the specifications mentioned on page 8.

3. Instructions for performing annual dose measurements in the low-dose range.

4. Specify any limitations for the respective device types/software versions.

5. If applicable, specify limitations for the reconstruction kernels to be used with regard to spatial resolution.

IV. What tasks should medical physics take on?

Creating, releasing, and monitoring the use of specific protocols

The Physics and Technology Working Group notes that, according to the provisions of the Radiation Protection Ordinance (Sec. 131 Sentence 2 Point 3), an MPE must be consulted for CT examinations. In addition, according to Sec. 132 Point 1, MPEs must be involved in physico-technical quality assurance activities.

EURATOM Directive 2013/59 (e.g. Article 83) already clearly tasks the MPE, in particular, with ensuring the proper management of radiation exposure [27].

The Physics and Technology Working Group thus recommends creating dedicated, clearly named examination protocols to be carried out with the involvement of the MPE designated for the CT scan. The initial approval for clinical use is granted by the experts in radiology and medical physics responsible for the device. Any changes to the initial protocols must be made in consultation with or approved by the responsible persons. Additionally, it must be ensured that only the approved protocols are used on the person examined as part of the screening program. Monitoring of the protocols used can be accomplished, for example, with the aid of a dose management system.

As part of a “local” quality assurance concept, the selected scan parameters should be taken into account in conjunction with the software used for computer-assisted detection. The stability of the relevant physico-technical parameters should be checked regularly (a monthly interval is recommended).

The Physics and Technology Working Group will develop and provide a best-practice guide for implementing this requirement and any additional tasks that may arise.

V. Are reference centers necessary for a successful screening program?

Re-evaluation of quality assurance

Although reference centers are not strictly necessary for the launch of the screening program, it is essential to establish them in the long term to ensure the process quality and long-term success of the screening program. Without a central and structured evaluation of the data collected, it will hardly be possible to scientifically evaluate the program. In order to generate valid information regarding the sensitivity and specificity of the screening program (detectability, false positive or false negative values, mortality, and morbidity), we currently see no alternative to establishing reference centers similar to those already being used successfully in mammography screening. The structured recording and analysis of patient data sets generated in the framework of lung cancer screening appears particularly relevant with regard to CT image quality and protocol parameters. This was already set out in the previous BfS report (BfS-34/21, 2021, item 3.9.1.3 and A.1.2.7 [22]).

These reference centers are intended, among other things, to issue recommendations on the following:

• suitable grayscale value (HU) window widths for diagnosis,

• possible field-of-view limitations,

• CTDI_vol lower limits depending on body size

• suitable reconstruction algorithms

and regular updates to these recommendations. This will enable practitioners to formulate a reliable, screening-based indication regarding the detectability of nodules depending on their size (volume in mm³) and density (attenuation in HU).

The permissible tolerances or fluctuations in dose and image quality needed to support valid volume determination are still in the process of being defined.

Outlook

In the framework of lung cancer early detection, little or no research has been conducted so far to determine the quality assurance measures that are meaningful in relation to technology.

Recently published studies showed that the deviations in volume determination for artificially created lesions were less than 30%. Therefore, the use of a special phantom for quality assurance does not appear necessary at present [8].

In the supplementary material to the position paper published jointly by the German Radiological Society, the German Society for Pneumology and Respiratory Medicine, and the German Society for Thoracic Surgery, a diameter of 4 mm (corresponding to 34 mm³ or 4–5 pixels) is considered relevant for determining volume doubling times (see the section “Modified Lung-RADS classification with volume doubling time”) [28].

Due to the current lack of data on physico-technical quality assurance in the low-dose range, it is considered necessary to scientifically monitor screenings. This includes, for example, the influence of reconstruction methods and filter kernels, image noise, and evaluation software used on volume determination as an essential parameter for Lung-RADS classification. This is especially true for small lesions. Only when relevant data are available can the quality assurance processes be evaluated and the specifications adjusted, as necessary.

It should be possible in the near future to develop a quality assurance package specifically adapted to the requirements of early lung cancer detection; in this package, physical parameters such as spatial resolution, noise, and contrast of the scan protocol could be regularly checked, for example, by using a phantom (possibly also in the form of an end-to-end test).

Future studies need to clarify how to deal with uncertainties arising from the variability of CT devices, protocols, and evaluation software in follow-up examinations. Standardized, manufacturer-independent protocols are not feasible due to very different approaches regarding dose and tube voltage automation, reconstruction methods used, etc. This position paper also refers to the obligation of manufacturers to provide – for all usable devices – suitable protocols that comply with the requirements of the ordinance.

Appendix

How should the restrictions on the device parameters to be selected from the appendix to Sec. 4 Para. 1 Sentence 1 of LuKrFrühErkV be interpreted?

The appendix to LuKrFrühErkV lists device parameters that must be adhered to when used in lung cancer screening.

The Physics and Technology Working Group has classified some of the parameters listed here, or their value ranges, as open to interpretation or even misleading, and has therefore – after consulting with the manufacturers – added some important specifications:

Pitch 0.9 to 1.2

Using this predefined range of values, high-pitch spirals are no longer possible with dual-source devices, even though they are more dose-efficient. This goes against the idea of optimization. It makes sense to give recommendations for selecting the pitch for individual devices; however, a general restriction to the values mentioned here does not appear to make sense.

Automatic voltage control

The general requirement to use what is known as an automatic tube voltage control system excludes manufacturers, and the working group does not consider such a requirement meaningful.

Adapting the protocols to the body mass index (BMI) of the person being examined is sufficient, as this ensures an almost constant image quality, regardless of the individual patient, and reduces radiation exposure accordingly. kV-modulation or tube voltage automation can potentially influence the image texture and thus affect the results of the volumetric analysis. Therefore, manufacturers should provide suitable examination protocols for lung cancer screening for the respective device type and the use of existing automated systems should be approved, also taking into account higher pre-filters (e.g. tin or silver).

Automatic exposure control/automatic tube current modulation

Adapting the protocols to the BMI of the person being examined is sufficient. The working group recommends adjusting the tube voltage (e.g. by means of automatic tube voltage control) and/or the tube current (e.g. by means of tube current modulation) to the body size.

Lateral resolution (x,y)

The remarks mention that an isotropic spatial resolution of 0.8 to 1.0 millimeters is required for contrasts of 150 Hounsfield units and higher. This could be changed to “nearly isotropic spatial resolution”, as a change in the field of view also entails a change in the resolution in (x,y).

Example: For an obese patient with a resulting FOV of 52 cm, the resolution in the (x,y) plane would be 520 mm/512 = 1.02 mm.

Dose value of 1.3 mGy

According to Sec. 1 of LuKrFrühErkV (Sec.1 (1), Paras. 1 and 2), “low-dose computed tomography [...] of the thorax is an application in which a volumetric computed tomography dose index (CTDI_vol) of 1.3 milligray is not exceeded or a higher volumetric computed tomography dose index than 1.3 milligray is necessary in individual cases due to the body size of the person being examined.” Following the announcement in the Federal Gazette of the scientific assessment by the Federal Office for Radiation Protection regarding early detection of lung cancer dated December 6, 2021 (BfS-34/21, 2021, point 3.6.1 Table 19), it should be noted that the 1.3 mGy value refers to a patient group with a BMI ≤ 26 kg/m2 and that state-of-the-art equipment allows for significantly lower values [22].

It would therefore make sense to have recommended values for CTDI_vol for several different body types, adjusted for BMI (e.g. based on the protocol recommendations for low-dose HRCT published by the Working Group on Diagnostic Radiology of Occupational and Environmental Diseases [21]).

In the HANSE study, CTDI_vol values of 0.8 to 1.6 mGy were observed, although only one device from one manufacturer was used [20].

List of abbreviations

BMI: body mass index

BfS: Federal Office for Radiation Protection [Bundesamt für Strahlenschutz]

CTDI_vol : volumetric computed tomography dose index

FOV: Field-of-View

LuKrFrühErkV: Lung Cancer Screening Ordinance [Lungenkrebsfrüherkennungsverordnung]

mGy: milligray

MPE: Medical physics expert

StrlSchG: German Radiation Protection Act [Strahlenschutzgesetz]

StrlSchV: German Medical Radiation Protection Ordinance [Strahlenschutzverordnung]

Conflict of Interest

The authors declare that they have no conflict of interest.

Acknowledgement

We would like to thank the manufacturers organised within the ZVEI for the helpful discussions during the preparation of this position paper.

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Publication History

Received: 29 April 2025

Accepted after revision: 18 November 2025

Article published online:
17 December 2025