NCT06335069 18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.
| NCT ID | NCT06335069 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Maastricht University Medical Center |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2025-09-01 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Female patient with histopathologically proven ER+ breast cancer. * Diagnosed with locally advanced (primary tumor \>5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, or metastatic breast cancer for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed. * Willing and able to undergo the study procedures. * Has personally provided written informed consent. Exclusion Criteria: * Age \<18 * Pregnancy * Patients with secondary malignancies (except non-melanoma skin cancer) * No 18F-FDG PET/CT or 18F-FDG PET/MRI scan. * Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity * Chronic inflammatory disease such as rheumatoid arthritis. * Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²) * Inability to provide informed consent.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06335069 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06335069 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06335069 currently recruiting?
Yes, NCT06335069 is actively recruiting participants. Contact the research team at thiemo.nijnatten@mumc.nl for enrollment information.
Where is the NCT06335069 trial being conducted?
This trial is being conducted at Maastricht, Netherlands.
Who is sponsoring the NCT06335069 clinical trial?
NCT06335069 is sponsored by Maastricht University Medical Center. The trial plans to enroll 20 participants.
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