64Cu-LLP2A Imaging for Blood Cancers

Recruiting in Palo Alto (17 mi)

Overseen byFarrokh Dehdashti, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Recruiting

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Farrokh Dehdashti, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

This trial is for individuals with confirmed diagnoses of various blood cancers, including multiple myeloma and different types of lymphoma. It's also open to those who've had a bone marrow transplant but are suspected of cancer recurrence despite negative imaging results.

Inclusion Criteria

Healthy Volunteer: Able to give informed consent

Healthy Volunteer: Able to comprehend and willing to follow instructions for study procedures as called for by the protocol

Healthy Volunteer: No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions

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Treatment Details

Interventions

64Cu-LLP2A (Cancer Vaccine)

Trial OverviewThe study is testing a new formulation called 64Cu-LLP2A using PET/CT scans to see if it can help diagnose blood cancers like multiple myeloma and lymphomas more accurately in patients, including those post-bone marrow transplant.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: Pilot/Cohort 1B: Dosimetry 64Cu-LLP2AExperimental Treatment2 Interventions

- 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)

Group II: Cohort 2B: Quantitative 64Cu-LLP2AExperimental Treatment2 Interventions

- 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.