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Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
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
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 moreSecondary 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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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Ralph Weissleder, MDLead Sponsor