Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
|Early Phase 1|
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Washington University School of Medicine|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Farrokh Dehdashti, M.D.|
|Principal Investigator Affiliation||Washington University School of Medicine|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Experimental: Cohort 1: Pilot 64Cu-LLP2A Imaging
12 adult individuals (6 patients with known MM; 6 healthy volunteers) All subjects who enter the study in Cohort 1 will be injected with 11 mCi (RANGE 8.8-13.2 mCi) of 64Cu-LLP2A and undergo body imaging twice within 0-30 hrs following administration of 64Cu-LLP2A to study tracer biodistribution and calculate human dosimetry Body imaging will be performed approximately at the following time points: Immediately after 64Cu-LLP2A administration (2 subjects 1 healthy volunteer and 1 subject with MM) 1 to 3 hours after 64Cu-LLP2A administration (4 subjects) 3 to 8 hours after 64Cu-LLP2A administration (4 subjects) 18 to 30 hours after 64Cu-LLP2A administration (2 subjects: 1 healthy volunteer and 1 subject with MM) 10 of the subjects will also undergo dynamic study for 60 mins immediately after administration of 64Cu-LLP2A.
Experimental: Cohort 2: Quantitative 64Cu-LLP2A Imaging
20 patients with MM will be recruited Subjects who enter on study in Cohort 2 will undergo a 60-min dynamic image over the known site of disease (OR pelvis and lower lumbar spine, if no site of disease is known). Following a simple DIXON MRI scan for attenuation correction, subjects will be injected with a dose of 11 mCi of 64Cu-LLP2A (RANGE 8.8 - 13.2 mCi) and a list mode dynamic imaging acquisition will begin for a total of 60 mins. Following the dynamic study, or at the optimal time point determined from cohort 1 imaging, after a simple DIXON scan for body (top of the head to below the knees) attenuation correction, emission scans (2-5 min per bed position) will be performed
Drug: - 64Cu-LLP2A
-64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)
Device: - PET/MR
-All PET imaging will be performed with a Siemens mMR PET/MR scanner
Procedure: - Blood samples for serum stability
-3 venous samples obtained from an IV site separate from the site of 64Cu-LLP2A injection (2 mL each) will be obtained at the following time points: Cohort 1: prior to injection, at completion of dynamic scanning in those who undergo dynamic imaging and at completion of one of the body imaging time points. In those who do not undergo dynamic imaging, prior to injection, and after completing body imaging at 2 of the 3 time points. Cohort 2: subjects will have samples drawn prior to injection, at completion of dynamic scanning, and at completion of body imaging.
Procedure: - Blood samples for metabolite analysis
-Typically, 2 blood samples obtained from an IV site separate from the site of 64Cu-LLP2A injection (preferably 1 within the first 5 min and 1 at the completion of the first hour of imaging) will be obtained.
Procedure: - Urine sample
-Cohort 1 only
Procedure: - Tumor biopsy
-Cohort 2 only and only if there hasn't been a recent biopsy of disease
Procedure: - Electrocardiogram
-A standard 12-lead ECG will be obtained on all subjects at baseline (within 30 mins prior to injection of 64Cu-LLP2A), and at least 60 minutes post injection or prior to study discharge
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.