FAP PET/CT for Staging Patients With Breast Cancer (NCT07523607) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
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.