64Cu-LLP2A for Imaging Hematologic Malignancies
NCT06636175 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 42
Last updated 2025-07-31
Summary
This phase of the protocol (protocol part B), seeks to evaluate the new formulation in healthy normal volunteers to confirm the new formulation provides comparable human dosimetry to which was seen and published in protocol part A. Additionally, the new formulation will be studied utilizing an expanded patient population to include patients with confirmed diagnosis of multiple myeloma (MM), low-grade lymphoma, or MM and lymphoma patients who are status post bone marrow transplant (BMT) with negative imaging and suspected recurrence.
Conditions
Interventions
- 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/CT
The results of 64Cu-LLP2A-PET/CT will not be provided to the patient or the treating oncologist/surgeon unless, in the judgment of the principal investigator, the images demonstrate an unsuspected abnormality that may warrant further evaluation.
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Washington University School of Medicine
lead OTHER
Principal Investigators
-
Farrokh Dehdashti, M.D. · Washington University School of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-02-26
- Primary Completion
- 2027-03-31
- Completion
- 2027-03-31
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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