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Clinical Trials in Italy / NCT06790264
Recruiting Not applicable

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

NCT06790264 · tracked via the Priya Life Science Italy tracker
Sponsor
European Institute of Oncology
Phase
Not applicable
Started
2024-11-01
Last updated
2025-01-27

Condition(s) studied

Breast Cancer InvasiveNode Positive Breast Cancer

Investigational drug(s) / intervention(s)

68Ga-FAPi-46 PET/CT

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate — 3 months
    Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT of positivity rate (percentage of detection of metastatic patients)

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting

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YOUNg Adults With Gastro-inteSTinal (GI) and nEuroendocrine canceRs. Recruiting
A New Tool to Promote Patient's Engagement in Their Healthcare Process Recruiting
Cognitive Impairment Assessment in Breast Cancer Survivors Starting soon
Molecular Phenotyping of Primitive Lung Cancer and Metastatic Site Recruiting

Other trials for the same condition

Metabolic Parameters and Quality of Life in Women on Neo-/Adjuvant Therapy for Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06790264 on ClinicalTrials.gov ↗ ← All trials in Italy