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[64]Cu Macrin for Cardiovascular Disease

Phase 1

Waitlist Available

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

No Placebo-Only Group

Summary

This trial tests a new imaging substance to see immune cells. It checks safety in healthy people and then examines its effectiveness in detecting disease areas in patients with cancer, sarcoidosis, or heart damage. The substance has been used in earlier studies to image immune cells in various conditions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

[64Cu] Macrin accuracy for macrophage localization

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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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