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

Evaluation of the Distribution of CM500 in Healthy Volunteers and Patients With Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans, CT scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests two radioactive imaging tracers, [64Cu]CM500 and [68Ga]CM500, used with PET-MRI or PET-CT scans. It will study how these tracers spread through the body and whether they may help find smaller solid tumors. Healthy adults and adults with solid tumor cancer may join.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be age 18 or older and able to give written consent.
  • People with cancer must have a known solid tumor. Any stage is allowed.
  • Healthy volunteers must be judged healthy based on their health history, exam, vital signs, and lab tests.
  • Healthy volunteers must have a negative drug test.
  • Healthy volunteers must have no history of blood clots or atrial fibrillation (an uneven heartbeat) with a stroke-risk score called CHA₂DS₂-VASc of 1 or higher.

Who can't join

  • You are pregnant or breastfeeding. People who could become pregnant must have a negative pregnancy test before joining.
  • You fear enclosed spaces, cannot lie comfortably in the scanner, or weigh over 300 pounds for MRI or 441 pounds for CT.
  • For PET-MRI scans: you have unsafe metal or electrical implants or objects, such as a pacemaker, pump, certain clips or valves, metal fragments, or certain tattoos.
  • Your research radiation exposure would exceed local limits, listed as 50 mSv in the past 12 months, or you joined another clinical study in the past 30 days.
  • You have ARDS (severe sudden lung failure), systemic sclerosis (a disease that hardens tissues), or rheumatoid arthritis unless well controlled with medicine. COPD (long-term lung disease) excludes you unless you need no extra oxygen and can lie in the scanner.
  • You receive cancer treatment that changes blood test results. You may join if the study doctor finds that your lab results stay stable between treatment cycles.
  • Your kidney filtering test, called eGFR, is below 60; your bilirubin liver test is over 1.5 times normal; or your AST/ALT liver tests are over 3 times normal, or 5 times normal if cancer has spread to the liver.
  • Your heart's electrical recovery time, called QTc, is 450 milliseconds or more for healthy volunteers or 470 or more for people with cancer. You also cannot join if you cannot give written consent or the study doctor finds the study unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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).

Study sites (3)

MA

MI

NY