Health Trials

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

ConditionsBladder CancerGliomaGlioblastoma (GBM)Breast CancerColorectal CancerEsophageal CancerGastric Cancer (GC)Pharynx CancerOral Cavity CancerKidney CancerLiver CancerLung Cancer (NSCLC)Ovarian CancerPancreatic CancerPDAC - Pancreatic Ductal AdenocarcinomaProstate Cancer
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorLumina Pharmaceuticals Inc

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • [64Cu]CM500

    Drug

    \[64Cu\]CM500 is a peptide-based PET radiopharmaceutical. \[64Cu\]CM500 is administered intravenously (IV)

  • [68Ga]CM500

    Drug

    \[68Ga\]CM500 is a peptide-based PET radiopharmaceutical. \[68Ga\]CM500 is administered intravenously (IV)

  • PET/MR

    Device

    Whole body imaging using a PET/MR scanner

  • PET/CT

    Device

    Whole body imaging using a PET/CT scanner

  • Blood Collection

    Procedure/Surgery

    A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: Healthy Volunteers [64Cu]CM500Active comparator 4 interventions
Group B: Cancer patients [64Cu]CM500Experimental treatment 4 interventions
Group C: Healthy volunteers [68Ga]CM500Active comparator 4 interventions
Group D: Cancer patients [68Ga]CM500Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Pharmacokinetics of the PET radiopharmaceuticals [64Cu]CM500 and [68Ga]CM500 in healthy volunteers through measurement of radioactivity in blood

Time frame
48 hours
2

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.

Time frame
36 hours
3

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.

Time frame
36 hours

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Lumina Pharmaceuticals Inc

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: