Can a new tracer reveal hidden tumors?
NCT ID NCT07781852
First seen Aug 24, 2026 · Last updated Aug 28, 2026 · Updated 3 times
Summary
This trial is testing two new imaging tracers, called CM500, to see if they can help detect solid tumors anywhere in the body. The tracers are given by injection and then used with PET scans to create detailed images. The study includes healthy volunteers and people with various cancers, such as bladder, breast, lung, and pancreatic cancer. The goal is to see if these tracers can find tumors more clearly and possibly spot smaller ones than current imaging methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two experimental PET imaging tracers, [64Cu]CM500 and [68Ga]CM500, given by injection, used with PET/MR or PET/CT scans.
- What this could lead to
- If successful, this could lead to a new imaging method that finds tumors earlier and more precisely, potentially improving cancer detection and treatment planning.
- What could go wrong
- This is an early-phase trial with a small number of participants, so the tracers may not work as hoped or may not be safe for wider use. The results are preliminary and need further validation.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion 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 Exclusion 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 exclusion criteria. A patient can be enrolled if the investigator determines the labs are stable between anti-cancer treatment cycles; * 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).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
Locations
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BAMF Health
Grand Rapids, Michigan, 49503, United States
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East River Medical Imaging
New York, New York, 10021, United States
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Massachussetts General Hospital
Boston, Massachusetts, 02114, United States
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