Breast Cancer DetectionPhase 2NCT07523607
FAP PET/CT for Staging Patients With Breast Cancer
A Phase 2 study testing 68Ga-FAP-2286 in people with Breast Cancer Detection, run by Odense University Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Detection
- What is being tested?
- 68Ga-FAP-2286
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: [⁶⁸Ga]Ga-FAP-2286 PET/CT for Staging and Restaging Patients With Newly Diagnosed Primary Breast Cancer: a Phase II Study (FAPILOUS)
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
- Being tested
- 68Ga-FAP-2286
- Keywords
- Breast cancer, PET/CT, FAP, FAPI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAP-2286Drug
One scan at baseline staging, and for those reciving NACT : one scan before surgery.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: 68Ga-FAP-2286 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: 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
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.
Measured: Baseline and up to approximately 6 months post-baseline.
Frequency, type, and clinical impact of incidental findings on [⁶⁸Ga]Ga-FAP-2286 PET/CT
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.
Measured: Baseline and up to approximately 6 months post-baseline (Pre-surgery, for patients receiving NACT)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Jun 2026 (estimated)
- Primary completionJan 2028 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer DetectionStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523607
- Sponsor's protocol ID
- 2025-521324-29-00
- Other IDs
- 2025
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [⁶⁸Ga]Ga-FAP-2286 PET/CT for Staging and Restaging Patients With Newly Diagnosed Primary Breast Cancer: a Phase II Study (FAPILOUS)
- ClinicalTrials.gov ID
- NCT07523607
- Acronym / sponsor ID
- 2025-521324-29-00
- Conditions
- Breast Cancer Detection
- Keywords
- Breast cancer, PET/CT, FAP, FAPI
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 65 participants (estimated)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAP-2286 PET/CT Imaging | Experimental | Drug: 68Ga-FAP-2286Patients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAP-2286One scan at baseline staging, and for those reciving NACT : one scan before surgery. | Drug | 68Ga-FAP-2286 PET/CT Imaging |
Primary outcome
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.
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)
Time frame: 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.
5 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68Ga-FAP-2286 in people with Breast Cancer Detection, run by Odense University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara E Dahlsgaard-Wallenius, MD (+45 53 57 45 55, sara.elisabeth.wallenius@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.