Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B
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.
Arms & 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.
Outcome measures
Primary
Organ dosimetry of participants
Confirm organ dosimetry in healthy subjects and in patients with various hematological malignancies is consistent with prior formulation of 64Cu-LLP2A (all of Cohort 1 + up to 10 cohort 2 subjects). Average organ activity concentration will be measured, and decay corrected by utilizing regions of interest (ROIs) drawn around all organ visible on 64Cu-LLP2A images. Activity organ residence times will be calculated by numerical or analytical integration of the time-activity curves. Uptake/clearance functional fits of mono- or bi-exponential functions will be performed and analytical integration, accounted for physical decay, will be performed. The calculated residence times will be used with the program OLINDA/EXM for 64Cu and using the adult human (female and male) model to calculate the individual organ radiation dose, the whole-body dose and the effective dose.
Time frame: Through completion of PET/CT scans (estimated to be up to 2 days)
Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse events
Follow-up telephone call or in person visit to assess for self-reported adverse events associated with injection of 64Cu-LLP2A or PET/CT imaging. Additional chart review can be performed as needed.
Time frame: From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total)
Secondary
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by overall quality of PET images
Time frame: Through completion of PET/CT scans (estimated to be up to 2 days)
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by bone marrow uptake
Time frame: Through completion of PET/CT scans (estimated to be up to 2 days)
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by tumor/background ratio
Time frame: Through completion of PET/CT scans (estimated to be up to 2 days)
Eligibility criteria
Study locations (1)
Washington University School of Medicine
St Louis, Missouri, 63110