RecruitingPhase 2NCT06335069

18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.

18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer - a Pilot Study.


Sponsor

Maastricht University Medical Center

Enrollment

20 participants

Start Date

Sep 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different PET scan tracers — the standard FDG and a newer one called FAPI-46 — to see which one better detects and maps estrogen receptor-positive (ER+) breast cancer throughout the body. Better imaging can lead to more accurate staging and treatment planning. **You may be eligible if...** - You are a female patient 18 or older - You have been diagnosed with ER-positive breast cancer that is locally advanced, recurrent, or metastatic - You are already scheduled for an FDG PET scan as part of your standard care - You are able and willing to undergo both scan types **You may NOT be eligible if...** - You are pregnant - You have another active cancer (other than non-melanoma skin cancer) - You have a chronic inflammatory disease such as rheumatoid arthritis - You have contraindications to PET/MRI (such as a pacemaker or severe claustrophobia) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI

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.


Locations(1)

Maastricht University Medical Center+

Maastricht, Netherlands

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NCT06335069


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