Study Results
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Basic Information
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TERMINATED
EARLY_PHASE1
10 participants
INTERVENTIONAL
2018-11-20
2021-10-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
SINGLE
Study Groups
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Cohort 1: Pilot 64Cu-LLP2A Imaging
* 16 adult individuals (6-8 patients with known MM; 6-10 healthy volunteers)
* All subjects who enter the study in Cohort 1 will be injected with up to 11 mCi of 64Cu-LLP2A and will undergo body imaging at least twice within 0-30 hrs following administration of 64Cu-LLP2A to study tracer biodistribution and calculate human dosimetry
* 6 subjects will also undergo dynamic study for 60 mins immediately after administration of 64Cu-LLP2A.
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)
PET/MR
-All PET imaging will be performed as PET/MR or PET/CT
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.
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.
Urine sample
-Cohort 1 only
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
PET/CT
-All PET imaging will be performed as PET/MR or PET/CT
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 imaging over the known site of disease (OR pelvis and lower lumbar spine, if no site of disease is known). Following a simple DIXON MRI or low dose CT scan for attenuation correction, subjects will be injected with a dose of up to11 mCi of 64Cu-LLP2A 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 or low dose CT scan for body (top of the head to below the knees) attenuation correction, emission scans (2-5 min per bed position) will be performed
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)
PET/MR
-All PET imaging will be performed as PET/MR or PET/CT
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.
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.
Tumor biopsy
-Cohort 2 only and only if there hasn't been a recent biopsy of disease
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
PET/CT
-All PET imaging will be performed as PET/MR or PET/CT
Interventions
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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)
PET/MR
-All PET imaging will be performed as PET/MR or PET/CT
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.
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.
Urine sample
-Cohort 1 only
Tumor biopsy
-Cohort 2 only and only if there hasn't been a recent biopsy of disease
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
PET/CT
-All PET imaging will be performed as PET/MR or PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
\*All types of active myeloma are eligible including both newly diagnosed and previously treated provided plans are to start a new treatment or restart a prior treatment.
* Healthy Volunteer Subjects: Adult 18 years of age or older with no known hematologic disorder such as anemia, leukemia, etc. who is considered healthy based on assessment by PI. (Cohort 1 only).
* Able to give informed consent.
* Does not have any exclusions related to PET/MR imaging: No implanted medical devices such as: pacemaker, defibrillator, neurostimulator, artificial heart valve, cerebral aneurysm clips, no accidental exposure to metal fragments (if applicable)
* If applicable for administration of contrast with MRI imaging subject must have a calculated GFR of at least 60 mg/mL/1.73 m\^2.
* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.
Exclusion Criteria
* Unable to tolerate up to 90 min of PET/MR or PET/CT imaging per imaging session.
18 Years
ALL
Yes
Sponsors
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Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Farrokh Dehdashti, M.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201807197
Identifier Type: -
Identifier Source: org_study_id
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