Not Yet RecruitingPhase 2

FAP PET/CT for Staging Patients With Breast Cancer

65 participantsStarted 2026-06-01

Plain-language summary

This study aims to evaluate the clinical utility of \[68Ga\]Ga-FAP-2268 PET/CT for disease staging and assessment in patients with high-risk primary breast cancer. By targeting fibroblast activation protein (FAP), this novel imaging approach may offer improved tumor visualization compared to conventional imaging, which may help improve treatment planning.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and females ≥ 18 years * Biopsy-verified newly diagnosed breast cancer * Can read and understand Danish * Capable of providing written and informed consent * Undergoing a routine \[¹⁸F\]FDG PET/CT scan as part of the clinical standard diagnostic workup Exclusion Criteria: * Pregnant or lactating women * Not able to participate in the conduct of the scan due to any reason ( e.g., claustrophobia or inability to lie still for entire imaging time) * Ongoing oncological treatment for another cancer * History of allergic reactions / hypersensitivity attributed to \[⁶⁸Ga\]Ga-FAP-2286.

What they're measuring

Number of patients with nodal and distant metastases detected by [⁶⁸Ga]Ga-FAP-2286 PET/CT at baseline (pre-treatment staging)

Timeframe: Baseline (pre-treatment). Inclusion period 1 year.

Concordance of [⁶⁸Ga]Ga-FAP-2286 PET/CT with surgical pathology for axillary lymph node status after neoadjuvant therapy (restaging)

Timeframe: Post-therapy/ pre-surgery scan, about 6 month after baseline scan.

Trial details

NCT IDNCT07523607

SponsorOdense University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-01

Contact for this trial

Sara E Dahlsgaard-Wallenius, MD

+45 53 57 45 55 sara.elisabeth.wallenius@rsyd.dk

View on ClinicalTrials.gov More Breast Cancer Detection trials