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

NCT07781852 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-08-24

No results posted yet for this study

Summary

The objective of this study is to assess two novel positron emission tomography (PET) radiotracers, \[64Cu\]CM500 and \[68Ga\]CM500, for PET-MR and 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.

Conditions

Interventions

DRUG

[64Cu]CM500

\[64Cu\]CM500 is a peptide-based PET radiopharmaceutical. \[64Cu\]CM500 is administered intravenously (IV)

DRUG

[68Ga]CM500

\[68Ga\]CM500 is a peptide-based PET radiopharmaceutical. \[68Ga\]CM500 is administered intravenously (IV)

DEVICE

PET/MR

Whole body imaging using a PET/MR scanner

DEVICE

PET/CT

Whole body imaging using a PET/CT scanner

PROCEDURE

Blood Collection

A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Lumina Pharmaceuticals Inc

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-09-01
Completion
2027-09-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07781852 on ClinicalTrials.gov