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[64]Cu Macrin for Cardiovascular Disease

Phase 1

Recruiting

Research Sponsored by Ralph Weissleder, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new drug, [64Cu] Macrin, to see if it is safe for humans and if it can help detect disease in people with cancer, sarcoidosis, or myocardial infarct.

Eligible Conditions

Cardiovascular Disease
Sarcoidosis
Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To establish human dosimetry of 64Cu Macrin in Healthy Volunteers

[64Cu] Macrin accumulation and detection in cancer

[64Cu] Macrin accumulation and detection in myocardial infarction

+1 more

Secondary outcome measures

[64Cu] Macrin accuracy for macrophage localization

Trial Design

4Treatment groups

Experimental Treatment

Group I: SarcoidosisExperimental Treatment1 Intervention

In 30 subjects with sarcoidosis the radiation dosimetry, normal organ distribution, and safety of [64Cu]-Macrin injection will be studied. In addition, the ability of [64Cu] Macrin to concentrate at the tumor site will be correlated with imaging and histopathology, where available.

Group II: Healthy VolunteersExperimental Treatment1 Intervention

In 10 healthy volunteers the radiation dosimetry, normal organ distribution, and safety of [64Cu]-Macrin injection will be studied.

Group III: Cardiovascular DiseaseExperimental Treatment1 Intervention

In 30 subjects with a history of recent myocardial infarct, the radiation dosimetry, normal organ distribution, and safety of [64Cu]-Macrin injection will be studied. In addition, the ability of [64Cu] Macrin to concentrate at the infarct site will be correlated with cardiac MRI.

Group IV: CancerExperimental Treatment1 Intervention

In 30 subjects with an epithelial malignancy the radiation dosimetry, normal organ distribution, and safety of [64Cu]-Macrin injection will be studied. In addition, the ability of [64Cu] Macrin to concentrate at the tumor site will be correlated with imaging and histopathology, where available.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ralph Weissleder, MDLead Sponsor

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment in this trial still open to participants?

"According to clinicaltrials.gov, recruitment for this project is still ongoing since its initial launch on September 6th 2021 and it's latest update on June 22nd 2022."

Answered by AI

Has the [64]Cu Macrin received authorization from the Food and Drug Administration?

"Owing to the early stage of clinical trials, our team at Power gave [64]Cu Macrin a score of 1 on their safety scale. This is because Phase 1 trials provide limited evidence for efficacy and safety."

Answered by AI

What is the scale of this experiment in terms of participants?

"Affirmative. As revealed on clinicaltrials.gov, the trial has been open for recruitment since September 6th 2021 and was amended lastly on June 22nd 2022; it is looking to engage 100 individuals from two individual sites."

Answered by AI

Is it feasible for me to join this medical experiment?

"To be eligible for inclusion, potential participants must have a diagnosed cardiovascular condition and fall within the range of 18 to 80 years old. Up to 100 individuals will ultimately be admitted into this clinical trial."

Answered by AI