Phase I Study of 68GaGa DOTA-5G PETCT Imaging for Detecting Metastatic or Advanced Invasive Lobular Breast Cancer

What this Trial Is About

Researchers are investigating the use of 68GaGa DOTA-5G PETCT imaging in patients diagnosed with metastatic or advanced invasive lobular breast cancer LBC. This phase I study aims to evaluate whether 68GaGa DOTA-5G can detect cancer lesions more sensitively than the current 18F-FDG PETCT scans, while also assessing the safety and tolerability of this imaging agent. Thirty patients will be enrolled over a two-year period to participate in this study. Participants will receive an injection of up to 5 mCi of 68GaGa DOTA-5G, followed by PETCT scans performed at one and two hours after injection. The study focuses on imaging patients to detect lesions and compare results with standard imaging methods. This is an interventional study without masking or placebo control, focusing solely on the experimental imaging agent. During the study, patients will undergo PETCT scans while remaining still for up to 30 to 60 minutes per scan. Researchers will monitor the ability of 68GaGa DOTA-5G PETCT to detect lesions within two hours of injection and assess safety by tracking adverse events for up to seven days after injection. The study will include assessments of blood tests, performance status, and tumor tissue availability. Participation will last from injection through follow-up safety monitoring.

[68Ga]Ga DOTA-5G as a Diagnostic Imaging Agent for Metastatic/Advanced Invasive Lobular Breast Cancer (LBC)