64Cu-LLP2A for Imaging Hematologic Malignancies
- Conditions
- Multiple MyelomaLow-Grade LymphomaFollicular LymphomaMarginal Zone LymphomaLymphoplasmacytic LymphomaSmall Lymphocytic LymphomaChronic Lymphocytic Leukemia
- Interventions
- Device: PET/CT
- Registration Number
- NCT06636175
- Lead Sponsor
- Washington University School of Medicine
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A 64Cu-LLP2A - Will be asked to undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points for purposes of calculating human dosimetry. Imaging time points will be dependent upon day of the week injection occurs: * Tuesday or Thursday injection: 0-60 minute multiple quick body scans + 120-180 min post injection body scan * Wednesday or Friday injection: 0-60 minute multiple quick body scans + 180-240 min post injection body scan * ALL PATIENTS: 15-28 hours post injection body scan on Wednesday (for Tuesday injection), Thursday (for Wednesday injection), Friday (for Thursday injection) or Saturday (for Friday injection) Pilot/Cohort 1B: Dosimetry 64Cu-LLP2A PET/CT - Will be asked to undergo 64Cu-LLP2A-PET/CT imaging at up to three separate time points for purposes of calculating human dosimetry. Imaging time points will be dependent upon day of the week injection occurs: * Tuesday or Thursday injection: 0-60 minute multiple quick body scans + 120-180 min post injection body scan * Wednesday or Friday injection: 0-60 minute multiple quick body scans + 180-240 min post injection body scan * ALL PATIENTS: 15-28 hours post injection body scan on Wednesday (for Tuesday injection), Thursday (for Wednesday injection), Friday (for Thursday injection) or Saturday (for Friday injection) Cohort 2B: Quantitative 64Cu-LLP2A 64Cu-LLP2A - Will be asked to undergo dynamic PET/CT imaging centered over a known target lesion (as determined by other radiological imaging studies) beginning with 64Cu-LLP2A-PET/CT and continuing for a total of 60 minutes. An additional vertex to upper thigh body scan will be obtained between 60- and 180-minutes post injection or at the optimal imaging time point that was derived from cohort 1B. Cohort 2B: Quantitative 64Cu-LLP2A PET/CT - Will be asked to undergo dynamic PET/CT imaging centered over a known target lesion (as determined by other radiological imaging studies) beginning with 64Cu-LLP2A-PET/CT and continuing for a total of 60 minutes. An additional vertex to upper thigh body scan will be obtained between 60- and 180-minutes post injection or at the optimal imaging time point that was derived from cohort 1B.
- Primary Outcome Measures
Name Time Method Organ dosimetry of participants Through completion of PET/CT scans (estimated to be up to 2 days) 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.
Safety and tolerability of new formulation of 64Cu-LLP2A as measured by number of participants with adverse events From beginning of administration of 64Cu-LLPA2A through last phone call assessment (up to 7 days total) 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.
- Secondary Outcome Measures
Name Time Method Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by overall quality of PET images Through completion of PET/CT scans (estimated to be up to 2 days) Overall, PET image quality will be graded visually (using 4-point scale with 1 being the worst and poor quality, not acceptable for diagnostic interpretation and 4 being good image quality, similar to routine clinical studies)
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by bone marrow uptake Through completion of PET/CT scans (estimated to be up to 2 days) As measured by placing ROI and calculating SUVmax where SUVmax is a mathematical measurement of tumor burden seen on images and calculated by the following equation SUVmax= r / (a'/w) where r= radioactivity concentration in tumor (kBq/ml) as measured by the PET scanner within a defined region of interest, a'=the decay corrected amount of injected 64Cu-LLP2A and w= weight of the patient in grams
Evaluate the quality of PET images with new formulation 64Cu-LLP2A as measured by tumor/background ratio Through completion of PET/CT scans (estimated to be up to 2 days) As measured by placing ROI and calculating SUVmax
Trial Locations
- Locations (1)
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States