REPOSE-Breast
Development and Validation of a Multimodal, Non-Rigid Registration Method for Hybrid Imaging of the Breast
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · University of Münster, Innovative Medical Research (IMF)
OTHER · Federal Office for Radiation Protection (Bundesamt für Strahlenschutz, BfS), Germany
interventional
20
1 country
1
Study Start
October 6, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The goal of this clinical trial is to improve the combined use of PET/CT and MRI for imaging of the breast. PET/CT and MRI are usually performed in different body positions, which can change the shape and position of the breast and make it difficult to accurately align findings between the two examinations. The main questions this study aims to answer are: Can dedicated breast positioning during PET/CT reduce differences in breast shape and position compared with MRI? Can image registration methods further improve the alignment of PET/CT and MRI images of the breast? How accurately can findings seen on PET/CT be transferred to the corresponding location on MRI? Participants in this study are breast cancer patients who are already scheduled to undergo PET/CT and PET/MRI as part of their clinical care. As part of the study, they will undergo an additional low-dose CT scan and an additional PET acquisition in a dedicated prone breast position. The additional PET images will be acquired using the tracer that has already been administered for the clinically indicated PET examination; no additional tracer injection is required. The imaging data will then be used to develop and evaluate different methods for aligning PET/CT and MRI images of the breast. The study does not investigate a new drug or treatment.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2, 2026
Actual (reported)October 6, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 20, 2026
Actual (reported)September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Target Registration Error After Multimodal Breast Image Registration
Target Registration Error (TRE) will be used to quantify the spatial accuracy of registration between corresponding breast imaging datasets. TRE will be calculated as the distance in mm between predefined corresponding anatomical or imaging reference points after registration. Lower TRE values indicate greater registration accuracy. Registration performance will be assessed for datasets acquired in different body positions and for datasets acquired in comparable prone breast positions.
Up to 4 months after completion of imaging acquisition for each participant
Mean Three-Dimensional Structural Similarity Index (3D-SSIM) Between Registered PET Datasets
Structural similarity between the registered PET datasets acquired as part of PET/CT and PET/MRI will be assessed using the three-dimensional Structural Similarity Index (3D-SSIM), implemented in Python using the scikit-image library. The index provides a dimensionless measure of similarity in spatial image patterns, with higher values indicating greater structural similarity and a value of 1 representing perfect similarity. The 3D-SSIM will be calculated within the registered breast image volume for each registration approach and acquisition setting to assess registration performance and the effect of comparable breast positioning on registration quality.
Participants undergo an additional PET acquisition and a low-dose CT scan in a dedicated prone breast position. The PET acquisition uses the radiotracer already administered for the clinically indicated PET examination; no additional tracer injection is required. The study-specific acquisition is performed to reduce positioning-related differences between PET/CT and breast MRI and to provide image data for subsequent multimodal image registration.
Participants undergo an additional PET acquisition and a low-dose CT acquisition in a dedicated prone breast position using a breast-specific positioning setup. The study-specific imaging procedure takes approximately 6-10 minutes. The PET acquisition is performed after the clinically indicated radiotracer administration and does not require an additional tracer injection. The study-specific acquisition is designed to reduce differences in breast shape and position between PET/CT and prone breast MRI and to provide image data for subsequent multimodal image registration.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Department of Nuclear Medicine, University Hospital Münster
Münster, North Rhine-Westphalia, 48149, Germany
First Submitted
October 2, 2026
First Posted
October 20, 2026
Study Start
October 6, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
Up to 4 months after completion of imaging acquisition for each participant
Absolute Difference in SUVmax After Image Deformation
Up to 4 months after completion of imaging acquisition for each participant
Absolute Difference in SUVmean After Image Deformation
Up to 4 months after completion of imaging acquisition for each participant
Absolute Difference in SUVpeak After Image Deformation
Up to 4 months after completion of imaging acquisition for each participant
Absolute Difference in SUVmax-Based Tumor-to-Background Ratio After Image Deformation
Up to 4 months after completion of imaging acquisition for each participant
Contact the study team to confirm eligibility.
September 30, 2027
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
September 30, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 20, 2026
Record last verified: 2026-10
Pseudonymized imaging data and associated study data may be shared with designated external research collaborators involved in the development and evaluation of image registration methods within the scope of this study. Subject to the participants' informed consent, data may also be shared with future research collaborators for related methodological research purposes. Any data sharing will be limited to the purposes permitted by the study documents and applicable data protection requirements. No unrestricted public release of individual participant data is planned.
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Source: ClinicalTrials.gov.
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