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The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Additional 68Ga-FAPI-46 PET/CT and PET/MRI exam | Experimental | All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and 68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI | Diagnostic Test | All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and 68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| To determine essential input parameters for an adequate sample size calculation for a diagnostic study that compares the diagnostic accuracy of 18F-FDG and 68Ga-FAPI-46 as PET tracer in patients with ER+ breast cancer. | To investigate the proportion of discordant pairs: the number of lesions detected on 18F-FDG PET but not on 68Ga-FAPI-46 PET and the number of lesions detected on 68Ga-FAPI-46 PET but not on 18F-FDG PET. | Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the feasibility of taking biopsies in test-positive patients. | The proportion of 68Ga-FAPI-46-positive 18F-FDG-negative lesions for which performing a biopsy is not feasible. | Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed. |
| Measure | Description | Time Frame |
|---|---|---|
| To provide preliminary estimates of the proportion of 68Ga-FAPI-46-positive and 18F-FDG-positive lesions confirmed as true positives and false positives verified by a histological biopsy (gold standard) in patients with ER+ breast cancer. | The proportion of 68Ga-FAPI-46-positive lesions and the proportion of 18F-FDG-positive lesions confirmed as true positives or false positives (verified by a biopsy, the gold standard) |
Inclusion Criteria:
Exclusion Criteria:
Only females are eligible to participate in this study.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thiemo JA van Nijnatten, MD, PhD | Contact | +31433876910 | thiemo.nijnatten@mumc.nl | |
| Lisa EHW Duijx, MSc | Contact | +31639289798 | lisa.duijx@mumc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center+ | Recruiting | Maastricht | 5800 | Netherlands |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Single-group, single-center pilot study
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| Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed. |
| To investigate the differences in accuracy between 68Ga-FAPI-46 PET/CT versus 68Ga-FAPI-46 PET/MRI. | Diagnostic performance will be compared between both exams (i.e. 68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI. | Patients will be followed from diagnosis until the additional imaging exams are performed, within 20 working days both PET exams will be performed. |