64Cu-LLP2A for Imaging Hematologic Malignancies

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Oct 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new imaging agent called 64Cu-LLP2A, which is designed to help doctors see and understand certain blood cancers better. The trial focuses on patients with conditions like multiple myeloma and various types of lymphoma. It aims to confirm that this new formulation is safe and effective for use in humans, particularly in patients who have already had treatments like bone marrow transplants and may have signs of cancer returning.

To participate in the trial, you need to be at least 18 years old and able to provide consent. If you have a confirmed diagnosis of multiple myeloma or lymphoma, you may be eligible. Healthy volunteers can also join if they meet certain criteria, like not having any history of claustrophobia (fear of enclosed spaces) and being able to lie still for about 75 minutes during imaging tests. Participants in the trial will undergo imaging procedures using a PET/CT scanner, which is a type of advanced imaging technology that helps doctors see inside the body. Throughout the process, the research team will ensure that you understand what to expect and are comfortable.

Gender

ALL

Eligibility criteria

• 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 currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative.
• Inclusion Criteria Hematological Malignancy:
• * Clinical or pathologically defined MM or lymphoma including both newly diagnosed, relapsed or refractory disease:
• • Multiple Myeloma defined in accordance with the International Myeloma Working Group criteria
• • Low-grade lymphoma, including the following subtypes: follicular lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia
• • Adult 18 years of age or older and able to provide informed consent
• • Capable of lying still and supine within the PET/CT scanner for up to 75 minutes.
• • No history of claustrophobia or other condition that has previously or would interfere with completion of protocol specified imaging sessions
• • Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post-menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 24 hour period immediately prior to administration of 64Cu-LLP2A) is negative
• • Patients participating in imaging or therapeutic trials with investigational agents are eligible to participate