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

NCT06790264 | Recruiting

• 1 other identifier: UID 4047
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Invasive; Node Positive Breast Cancer

Keywords

68Ga-FAPi-46 PET/CT

Outcome Measures

Primary Outcomes (1)

• Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate

  Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT of positivity rate (percentage of detection of metastatic patients)

  3 months

Study Arms (1)

68Ga-FAPi-46 PET/CT

EXPERIMENTAL

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

Procedure: 68Ga-FAPi-46 PET/CT

Interventions

68Ga-FAPi-46 PET/CT PROCEDURE

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

68Ga-FAPi-46 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy, 20141, Italy

RECRUITING

Study Officials

• Francesco Ceci, MD

  European Istitute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Ceci

CONTACT

+390257489315; francesco.ceci@ieo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 17, 2025
• First Posted: January 24, 2025
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)