Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer (FAPI-PET)

January 23, 2025 updated by: European Institute of Oncology

Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer. a Phase II Study to Evaluate the Comparison of 68Ga-FAPi-46 and 18F-FDG Uptake in Patients with Different Breast Cancer Subtypes

This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients affected by newly diagnosed, clinically N-positive BC that have already undergone a baseline 2-deoxy-2-[fluorine-18]fluoro-D-glucose (18F-FDG) PET/CT (T1) will be screened for eligibility. Patients who will meet all inclusion/exclusion criteria will be considered eligible and asked to participate to the study after signing the informed consent form. Patients' eligibility will be evaluated by the referent nuclear medicine physician (T2). Considering the clinical experience of the investigators, we expect to complete patient enrolment in 12 months after study accrual

Study Type

Interventional

Enrollment (Estimated)

92

Phase

  • Not Applicable

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 Locations

  • Italy
      • Milan, Italy, 20141
        • Recruiting
        • European Institute of Oncology
        • Contact:

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly diagnosed, biopsy proven breast cancer;
  • Diagnosis of invasive breast cancer;
  • Tumor diameter more than 2 centimeters;
  • Radiological evidence of axillary nodes involvement;
  • 18F-FDG PET/CT performed as baseline diagnostic procedure, during routine diagnostic work-up;
  • 68Ga-FAPi-46 PET/CT performed within 4 weeks from 18F-FDG PET/CT;
  • Patients suitable to primary treatment (surgery or neo-adjuvant therapy);
  • 68Ga-FAPi-46 PET/CT performed within 8 weeks from primary treatment;
  • Female patients;
  • Age ≥18;
  • Willing to sign informed consent form.

Exclusion Criteria:

  • Pregnant or nursing patients;
  • Unable to stay flat and cannot tolerate PET scan;
  • Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression;
  • Eastern Cooperative Oncology Group (ECOG) performance status ≥2.

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
Intervention / Treatment
Experimental: 68Ga-FAPi-46 PET/CT
Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT
Procedure: 68Ga-FAPi-46 PET/CT
Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate
Time Frame: 3 months
Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT of positivity rate (percentage of detection of metastatic patients)
3 months

Collaborators and Investigators

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

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Francesco Ceci, MD, European Istitute of Oncology

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 (Actual)

November 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UID 4047

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

product manufactured in and exported from the U.S.

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.

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