FAP PET/CT for Staging Patients With Breast Cancer

NCT07523607 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: 2025-521324-29-00
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer Detection

Keywords

Breast cancer; PET/CT; FAP; FAPI

Outcome Measures

Primary Outcomes (2)

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

  Nodal and distant metastases will be identified on a per-patient and per-lesion basis using \[⁶⁸Ga\]Ga-FAP-2286 PET/CT in 65 patients undergoing baseline staging. PET/CT images will be read blinded. The reference standard is histopathology where available; if histopathology is not available, a composite of clinical and imaging follow-up will be used. Sensitivity and specificity with 95% confidence intervals will be calculated per patient and per lesion.

  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)

  In approximately 50 patients undergoing post-neoadjuvant therapy PET/CT prior to surgery, axillary lymph node status will be classified as (a) uptake on PET/CT with histologically confirmed residual disease, or (b) no uptake on PET/CT with pathological complete response (pCR). PET/CT images will be read blinded, with surgical pathology as the gold standard. Concordance (proportion correctly classified) and appropriate concordance statistics will be calculated.

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

Secondary Outcomes (5)

• Number of patients with TNM stage or MDT treatment decision changes after [⁶⁸Ga]Ga-FAP-2286 PET/CT

  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

  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

  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

  Baseline and up to approximately 6 months post-baseline.

• Frequency, type, and clinical impact of incidental findings on [⁶⁸Ga]Ga-FAP-2286 PET/CT

  Baseline and up to approximately 6 months post-baseline (Pre-surgery, for patients receiving NACT)

Study Arms (1)

68Ga-FAP-2286 PET/CT Imaging

EXPERIMENTAL

Patients undergo intravenous administration (200 MBq) of 68Ga-FAP-2286 followed by PET/CT imaging for staging of high-risk primary breast cancer. A baseline scan is performed prior to initiation of therapy. Patients receiving neoadjuvant chemotherapy undergo an additional scan prior to surgery.

Drug: 68Ga-FAP-2286

Interventions

68Ga-FAP-2286 DRUG

One scan at baseline staging, and for those reciving NACT : one scan before surgery.

68Ga-FAP-2286 PET/CT Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Sara E Dahlsgaard-Wallenius, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: April 13, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share