RecruitingEarly Phase 1NCT06636175

64Cu-LLP2A for Imaging Hematologic Malignancies

Early Phase I Evaluation of 64Cu-LLP2A for Imaging Hematologic Malignancies Part B


Sponsor

Washington University School of Medicine

Enrollment

42 participants

Start Date

Feb 26, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a new imaging agent called 64Cu-LLP2A that uses a PET/CT scanner to detect blood cancers like multiple myeloma and certain types of lymphoma. Researchers want to see how well this agent can find cancer in the body. Healthy volunteers are also needed to compare normal scan results. **You may be eligible if...** - You are 18 or older - You are a healthy volunteer OR you have been diagnosed with multiple myeloma, follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, or small lymphocytic lymphoma/chronic lymphocytic leukemia - You can lie still in a PET/CT scanner for up to 75 minutes - You are not pregnant or breastfeeding **You may NOT be eligible if...** - You have a history of claustrophobia that would prevent you from completing the scan - You have used illicit or inhaled drugs in the past year (healthy volunteers only) - You are pregnant or nursing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT06636175


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