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

Study summary

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.

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Key things to know

Main goalDiagnostic

This describes the study’s primary purpose.

What is being studied[64Cu]CM500 and [68Ga]CM500

Plus 3 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC)

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 28, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Not Yet Recruiting

The study is not accepting participants yet.

What kind of study?Early Phase 1

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Lumina Pharmaceuticals Inc

Study sponsor

Study overview

What this study is about

Purpose: Diagnostic
Study type: Interventional
Phase: Early Phase 1
Sponsor: Lumina Pharmaceuticals Inc
Interventions being studied: Drug: [64Cu]CM500; Drug: [68Ga]CM500; Device: PET/MR; Device: PET/CT; Procedure: Blood Collection

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

For healthy subjects:
18 years of age or older;
Deemed healthy at screening visit based on the following assessments: physical examination, height and weight, medical history, and blood pressure, pulse, temperature, pulse oximetry, heart rhythm, and respiratory rate. labs within the previous month can be utilized to determine eligibility;
No known history of atrial fibrillation with CHA₂DS₂-VASc score of 1 or higher, or history of thrombosis;
Negative drug screen;
Have the ability to give written informed consent.
For patient subjects with presence of cancer:
Known solid tumor cancer at any stage
18 years of age or older
Ability to give written informed consent

Reasons someone may not be able to joinExclusion criteria

Less than 18 years of age;
Electrical implants such as cardiac pacemaker or perfusion pumps (MR-PET only);
Pregnant or breastfeeding (a negative STAT quantitative serum or urinary hCG pregnancy test is required for females having child-bearing potential before the subject can participate);
Claustrophobic reactions;
Subjects will be excluded if research-related radiation exposure exceeds current local institutional guidelines (i.e. 50 mSv in the prior 12 months);
Unable to lie comfortably on a bed inside a PET scanner;
Body weight over the weight limit for the moving table (\> 300 lbs for the MRI table and \>441 lbs for the CT table);
Metallic or electric implants contraindicated for MR-PET scanning when applicable (that is, if MRI is anticipated to be used as part of the study); such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, or steel implants ferromagnetic objects such as jewelry or metal clips in clothing;
Diagnosis of the following conditions: acute respiratory distress syndrome (ARDS), systemic sclerosis, rheumatoid arthritis (unless disease activity is well-controlled with medication), or chronic obstructive pulmonary disease (COPD) unless COPD is managed on room air and subject can tolerate laying on a scanner;
Participation in another clinical study or therapeutic clinical trial in the past 30 days;
Under treatment of chemotherapy that would alter blood tests. Other anti-cancer medications while enrolling to trial (RLT, immunotherapy, targeted therapy) also apply to this

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Massachussetts General HospitalBoston, Massachusetts
BAMF HealthGrand Rapids, Michigan
East River Medical ImagingNew York, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 28, 2026. Always confirm current availability with the study team.

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