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

NCT ID: NCT06790264

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 92 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2025-11-30

Brief Summary

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.

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

Conditions

Breast Cancer Invasive; Node Positive Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-FAPi-46 PET/CT

Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT

Group Type: EXPERIMENTAL

68Ga-FAPi-46 PET/CT

Intervention Type: PROCEDURE

Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT

Interventions

68Ga-FAPi-46 PET/CT

Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francesco Ceci, MD

Role: PRINCIPAL_INVESTIGATOR

European Istitute of Oncology

Locations

European Institute of Oncology

Milan, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Francesco Ceci

Role: CONTACT

francesco.ceci@ieo.it

+390257489315

Facility Contacts

Francesco Ceci

Role: primary

francesco.ceci@ieo.it

+390257489315

Other Identifiers

UID 4047

Identifier Type: -

Identifier Source: org_study_id