Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B
Washington University School of Medicine
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria Healthy Volunteer: * Adult 18 years of age or older * Able to give informed consent. * Able to comprehend and willing to follow instructions for study procedures as called for by the protocol * Capable of lying still and supine within the PET/CT scanner for up to 75 minutes. * No illicit drug use or other inhaled drug use (including pharmacologic agents and illicit drugs) within the past year per self-reporting mechanisms. * No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions. * Not cu…
Interventions
- Drug64Cu-LLP2A
64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)
- DevicePET/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.
Location
- Washington University School of MedicineSt Louis, Missouri