Breast Cancer Detection
Conditions
Keywords
Breast cancer, PET/CT, FAP, FAPI
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.
Interventions
DRUG68Ga-FAP-2286
One scan at baseline staging, and for those reciving NACT : one scan before surgery.
Sponsors
Odense University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with nodal and distant metastases detected by [⁶⁸Ga]Ga-FAP-2286 PET/CT at baseline (pre-treatment staging) | Baseline (pre-treatment). Inclusion period 1 year. | 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. |
| Concordance of [⁶⁸Ga]Ga-FAP-2286 PET/CT with surgical pathology for axillary lymph node status after neoadjuvant therapy (restaging) | Post-therapy/ pre-surgery scan, about 6 month after baseline scan. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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. |
| Incidence, severity, and causality of AEs, SAEs, and SUSARs after [⁶⁸Ga]Ga-FAP-2286 administration | From tracer injection to 48 hours post-injection | 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. |
| 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. | 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. |
| 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) | Incidental findings will be documented per patient at baseline , and for patients receiving neoadjuvant chemotherapy, on pre-surgery scans. This will include numbers of incidental findings, type, and clinical consequences. Proportions of incidental findings leading to additional diagnostic procedures (e.g., biopsy, MRI, CT) or clinical intervention will be reported descriptively. |
Contacts
CONTACTSara E Dahlsgaard-Wallenius, MD
Outcome results
None listed