Can a new tracer reveal hidden tumors?

NCT ID NCT07781852

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    3 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • BAMF Health

    Grand Rapids, Michigan, 49503, United States

  • East River Medical Imaging

    New York, New York, 10021, United States

  • Massachussetts General Hospital

    Boston, Massachusetts, 02114, United States

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