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NCT07781852 · ClinicalTrials.gov record · last posted 2026-08-25

Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer

StatusNot Yet Recruiting
PhaseEarly Phase 1
Started2026-09-01
View on ClinicalTrials.gov ↗
from the ClinicalTrials.gov record
The objective of this study is to assess two novel positron emission tomography (PET) radiotracers, \[64Cu\]CM500 and \[68Ga\]CM500, for Positron Emission Tomography-Magnetic Resonance Imaging (PET-MR) and Positron Emission Tomography / Computed Tomography (PET-CT) imaging of solid tumors. These tracers have the potential to detect solid tumors throughout the body and may enable doctors to identify smaller tumors than conventional imaging techniques.

Protocol amendment history 1 change detected by DataLookout

2026-08-26
Primary endpoint(s) modified
WasComplete blood count, Standardized uptake value, Time activity curve
NowDosimetry and radiation burden of [64Cu]CM500 and [68Ga]CM500, Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood, Standardized uptake value
Trial Details
NCT Number NCT07781852
Lead Sponsor Lumina Pharmaceuticals Inc
Collaborators: National Cancer Institute (NCI)
Conditions Bladder Cancer, Glioma, Glioblastoma (GBM), Breast Cancer, Colorectal Cancer, Esophageal Cancer, Gastric Cancer (GC), Pharynx Cancer +8 more
Enrollment 40 participants
Start Date 2026-09-01
Primary Completion 2027-09-01 (estimated)
Study Completion 2027-09-01 (estimated)
Updated on ClinicalTrials.gov 2026-08-25