FAP PET/CT for Staging Patients With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-FAP-2286.
- Who it may be relevant to
- Registry conditions: Breast Cancer Detection. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
[⁶⁸Ga]Ga-FAP-2286 PET/CT for Staging and Restaging Patients With Newly Diagnosed Primary Breast Cancer: a Phase II Study (FAPILOUS)
Overview
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.
Interventions
- Drug 68Ga-FAP-2286
One scan at baseline staging, and for those reciving NACT : one scan before surgery.
Primary outcome measures
- Number of patients with nodal and distant metastases detected by [⁶⁸Ga]Ga-FAP-2286 PET/CT at baseline (pre-treatment staging) [Time frame: 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) [Time frame: Post-therapy/ pre-surgery scan, about 6 month after baseline scan.]
Secondary outcome measures (5)
- Number of patients with TNM stage or MDT treatment decision changes after [⁶⁸Ga]Ga-FAP-2286 PET/CT [Time frame: Baseline (pre-PET/CT) and up to 7 days post-PET/CT at MDT review]
- Inter-reader agreement of [⁶⁸Ga]Ga-FAP-2286 PET/CT lesion detection, BI-RADS-like scoring, and SUV/TBR quantification [Time frame: Baseline (initial reading) and up to 18 months post-baseline for blinded second reading]
- Incidence, severity, and causality of AEs, SAEs, and SUSARs after [⁶⁸Ga]Ga-FAP-2286 administration [Time frame: From tracer injection to 48 hours post-injection]
- Lesion-level [⁶⁸Ga]Ga-FAP-2286 uptake patterns (SUVmax, SUVmean, LBR) across tumor subtypes and anatomical sites [Time frame: Baseline and up to approximately 6 months post-baseline.]
- Frequency, type, and clinical impact of incidental findings on [⁶⁸Ga]Ga-FAP-2286 PET/CT [Time frame: Baseline and up to approximately 6 months post-baseline (Pre-surgery, for patients receiving NACT)]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07523607 · 2025-521324-29-00