Testing new PET scan tracers in healthy adults and people with cancer
Tests two imaging tracers in healthy adults and adults with solid tumors.
Plain-language title generated from the registry record
Registry title: Evaluation of the Distribution of 64Cu/68Ga Labeled CM500 in Healthy Volunteers and Patients With Cancer
Key facts
- Where
- Boston, Grand Rapids, and New York, United StatesSee the 3 sites
- Phase
- Early phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for healthy adults and adults with a known solid tumor cancer, to study how two new PET scan tracers spread in the body.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Patients need a known solid tumor cancer at any stage. Healthy volunteers can also join.
- Earlier treatment
- Cannot join if in another clinical study in the past 30 days. Cannot join if on chemotherapy or other anti-cancer treatment that changes blood tests, unless the investigator finds the labs stable between cycles.
Main reasons for not taking part
- Pregnant or breastfeeding
- Pacemaker, electrical implants or metal implants that are unsafe for MR-PET scanning
- Claustrophobia or unable to lie comfortably in a PET scanner
- Moderate to severe kidney or liver problems
- Research radiation dose too high, for example over 50 mSv in the prior 12 months
Read by machine on 9 November 2026.
Where in United States
- Massachussetts General HospitalBoston, United StatesNo longer taking part
- BAMF HealthGrand Rapids, United StatesNo longer taking part
- East River Medical ImagingNew York, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lumina Pharmaceuticals Inc
- Trial code
- NCT07781852
- Record updated
- 28 August 2026
- Original description
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.Read full original descriptionShow less
Evaluation of the Distribution of CM500 in Healthy Volunteers and Patients With Cancer
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.
Inclusion: 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.
Exclusion: Subjects will be excluded if research-related radiation exposure exceeds current local institutional guidelines (i.e. 50 mSv in the prior 12 months); 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; Electrical implants such as cardiac pacemaker or perfusion pumps (MR-PET only); 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; 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 exclusion criteria. A patient can be enrolled if the investigator determines the labs are stable between anti-cancer treatment cycles; 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); 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); Less than 18 years of age; Claustrophobic reactions; 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); Participation in another clinical study or therapeutic clinical trial in the past 30 days; 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).