FAP PET/CT for Staging Patients With Breast Cancer

April 8, 2026 updated by: Odense University Hospital

[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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
65

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 68Ga-FAP-2286 PET/CT Imaging
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
One scan at baseline staging, and for those reciving NACT : one scan before surgery.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
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.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
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.
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.
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)
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.
Baseline and up to approximately 6 months post-baseline (Pre-surgery, for patients receiving NACT)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Odense University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 9, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-521324-29-00

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings