Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer
2 other identifiers
interventional
40
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Sep 2026
Shorter than P25 for early_phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2026
CompletedFirst Posted
Study publicly available on registry
August 24, 2026
CompletedStudy Start
First participant enrolled
September 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
Study Completion
Last participant's last visit for all outcomes
September 1, 2027
August 28, 2026
August 1, 2026
1 year
August 19, 2026
August 27, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood
48 hours
Standardized uptake value
The standardized uptake value (SUV) of \[64Cu\]CM500 and \[68Ga\]CM500 in solid tumors and in the various organs of interest (heart, liver, spleen, kidney, lung and any other organ that exhibits uptake) will be collected.
36 hours
Dosimetry and radiation burden of [64Cu]CM500 and [68Ga]CM500
Organs assessed include, but are not limited to, the heart, liver, spleen, kidney, and urinary bladder.
36 hours
Study Arms (4)
Healthy Volunteers [64Cu]CM500
ACTIVE COMPARATORUp to six (6) healthy adult subjects will be injected with \[64Cu\]CM500 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using Positron Emission Tomography-Magnetic Resonance Imaging (PET/MR) or Positron Emission Tomography / Computed Tomography (PET/CT). Healthy subjects will undergo blood collection before, during, and after the scan. An interim review of the data will be conducted after the first three subjects receive the study agent and complete all safety assessments.
Cancer patients [64Cu]CM500
EXPERIMENTALUp to thirty-four (34) cancer patients will be injected with \[64Cu\]CM500 and then undergo PET/CT or PET/MR. Patient subjects will undergo blood collection before and after the scan.
Healthy volunteers [68Ga]CM500
ACTIVE COMPARATORUp to six (6) healthy adult subjects will be injected with \[68Ga\]CM500 to establish the safety, whole body distribution, metabolism, pharmacokinetics, and radiation burden of the probe. All subjects will be imaged using PET/MR or PET/CT. Healthy subjects will undergo blood collection before, during, and after the scan. An interim review of the data will be conducted after the first three subjects receive the study agent and complete all safety assessments
Cancer patients [68Ga]CM500
EXPERIMENTALUp to thirty-four (34) cancer patients will be injected with \[68Ga\]CM500 and then undergo PET/CT or PET/MR. Patient subjects will undergo blood collection before and after the scan.
Interventions
\[64Cu\]CM500 is a peptide-based PET radiopharmaceutical. \[64Cu\]CM500 is administered intravenously (IV)
\[68Ga\]CM500 is a peptide-based PET radiopharmaceutical. \[68Ga\]CM500 is administered intravenously (IV)
Whole body imaging using a PET/MR scanner
Whole body imaging using a PET/CT scanner
A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
Eligibility Criteria
You may qualify if:
- For healthy subjects:
- 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
- years of age or older
- Ability to give written informed consent
You may not qualify if:
- 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;
- Moderate to severe renal impairment; must meet requirement of minimum eGFR of 60 mL/min/1.73 m²
- Moderate to severe hepatic impairment; must meet requirements of bilirubin ≤1.5 times the upper limit of normal (ULN), and AST/ALT ≤3 times ULN (or ≤5 times ULN with liver metastases)
- Baseline QTc interval ≥ 450 msec (healthy participants) or ≥ 470 msec (patients)
- Unable to give written informed consent;
- Determined by the investigator(s) to be clinically unsuitable for the study (e.g. based on screening visit and/or during study procedures).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)collaborator
- Lumina Pharmaceuticals Inclead
Study Sites (3)
Massachussetts General Hospital
Boston, Massachusetts, 02114, United States
BAMF Health
Grand Rapids, Michigan, 49503, United States
East River Medical Imaging
New York, New York, 10021, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2026
First Posted
August 24, 2026
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
August 28, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share