NCT04480619

Safety and Efficacy of Ga68-IAC PET/CT for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients

Safety and Efficacy of Ga-68-IAC Positron Emission Tomography (PET/CT) for Diagnosis and Clinical Management in Metastatic Breast Cancer Patients.

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Advanced Imaging Projects, LLC · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/IIa, open label, multicenter interventional study of Gallium-68 radiolabeled Integrin Adhesion Complex antagonist conjugate (Ga-68-IAC) Positron Emission Tomography (PET/CT) imaging, intended for diagnosis, and clinical management of patients with Metastatic breast cancer.

Detailed description

This is a prospective non blinded trial, Phase I/IIa, multicenter, study in a total of up to 25 subjects with angiogenic therapy indication for breast cancer. All patients with confirmed diagnoses will undergo \[18F\]Fluoro-deoxyglucose (18F-FDG) PET/CT (6-12 mCi) and Ga-68-IAC PET/CT 2-5 mCi to evaluate safety, biodistribution, and response to treatment in metastatic breast cancer patients.

Conditions

• Angiogenic Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ga-68-IAC	Clinical management and diagnosis of Metastatic Breast Cancer.

Timeline

• Start date: 2025-10-30
• Primary completion: 2027-05-30
• Completion: 2027-08-30
• First posted: 2020-07-21
• Last updated: 2025-07-16

Locations

3 sites across 2 countries: India, South Africa

Regulatory

• FDA-regulated drug study