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FAP PET/CT for Staging Patients With Breast Cancer

ConditionBreast Cancer Detection
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOdense University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and females ≥ 18 years

Biopsy-verified newly diagnosed breast cancer

Can read and understand Danish

Capable of providing written and informed consent

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 68Ga-FAP-2286

    Drug

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

Treatment groups

65 Participants
are divided into 1 treatment group
Group A: 68Ga-FAP-2286 PET/CT ImagingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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)

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.

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

Secondary outcomes

1

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

For baseline staging (approximately 65 patients), TNM stage and MDT treatment decisions will be compared before and after availability of \[⁶⁸Ga\]Ga-FAP-2286 PET/CT results. Proportions of patients with changes will be reported with 95% confidence intervals (Wilson-score method). Data will be extracted from eCRF documentation.

Time frame
Baseline (pre-PET/CT) and up to 7 days post-PET/CT at MDT review
2

Inter-reader agreement of [⁶⁸Ga]Ga-FAP-2286 PET/CT lesion detection, BI-RADS-like scoring, and SUV/TBR quantification

All baseline scans will be independently read by two blinded physicians. Lesions will be scored using a standardized Likert-type scale for presence, risk of malignancy, and clinical relevance on a per-patient and per-lesion basis. Quantitative uptake will be measured using SUVmax, SUVmean, and lesion-to-background ratio (LBR). Interobserver agreement for categorical measures will be quantified with (linearly weighted) Cohen's kappa; for continuous measures, Bland-Altman analysis and intraclass correlation coefficients (ICC) will be used.

Time frame
Baseline (initial reading) and up to 18 months post-baseline for blinded second reading
3

Incidence, severity, and causality of AEs, SAEs, and SUSARs after [⁶⁸Ga]Ga-FAP-2286 administration

Adverse events will be recorded for 48 hours post-injection, assessed per CTCAE v6.0. Data will include incidence, severity, and causality of AEs, SAEs, and SUSARs. Descriptive statistics will summarize findings by type, severity, and relation to the tracer.

Time frame
From tracer injection to 48 hours post-injection
4

Lesion-level [⁶⁸Ga]Ga-FAP-2286 uptake patterns (SUVmax, SUVmean, LBR) across tumor subtypes and anatomical sites

ROI-based quantification will be performed for primary tumors, axillary lymph nodes, and suspected distant lesions. Uptake metrics (SUVmax, SUVmean, LBR) will be summarized per lesion, stratified by histological and molecular subtype, and anatomical site using descriptive statistics.

Time frame
Baseline and up to approximately 6 months post-baseline.

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Odense University Hospital

Lead sponsor

Source ClinicalTrials.gov

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