This early phase I trial studies whether 64Cu-LLP2A can be used during positron emission tomography (PET)/computed tomography (CT) for the imaging of hematologic malignancies. PET is a procedure in which a small amount of radiotracer is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the radiotracer is used. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the patient’s body. 64Cu-LLP2A binds to and is taken up by very-late-antigen-4 (VLA-4)-expressing cancer cells. Upon PET, the VLA-4-expressing cancer cells can be visualized, and the cancer can be assessed to see how active the cancer is in the body. This may be effective for the imaging of hematologic malignancies.
Additional locations may be listed on ClinicalTrials.gov for NCT06636175.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Farrokh Dehdashti
Phone: 314-362-1474
PRIMARY OBJECTIVES:
I. Confirm organ dosimetry in healthy subjects and in patients with various hematological malignancies is consistent with prior formulation of copper Cu 64-CB-TE1A1P-PEG4-LLP2A (64Cu-LLP2A) (all of cohort 1 + up to 10 cohort 2 subjects).
II. Evaluate safety and tolerability of new formulation 64Cu-LLP2A.
SECONDARY OBJECTIVES:
I. Evaluate the quality of PET images with new formulation.
II. Compare PET images with standard of care radiological imaging such as fludeoxyglucose F-18 (FDG)-PET, when available. (Cohort 2)
OUTLINE: Participants are assigned to 1 of 2 cohorts.
COHORT 1B:
TUESDAY OR THURSDAY INJECTION: Participants receive 64Cu-LLP2A intravenously (IV) and undergo multiple quick body PET/CT scans over 3-5 seconds at 6, 8, 10, 12, 15, 20, 25, 30-, 40-, 50-, and 60-minutes post-injection. Participants then undergo PET/CT over 20-30 minutes at 120-180 minutes post-injection followed by PET/CT over 45 minutes at 15-28 hours post-injection.
WEDNESDAY OR FRIDAY INJECTION: Participants receive 64Cu-LLP2A IV and undergo multiple quick body PET-CT scans over 3-5 seconds at 6, 8, 10, 12, 15, 20, 25, 30-, 40-, 50- and 60-minutes post-injection. Participants then undergo PET/CT over 20-30 minutes at 180-240 minutes post-injection followed by PET/CT over 45 minutes at 15-28 hours post-injection.
All participants also undergo collection of urine and blood samples on study.
COHORT 2B: Patients receive 64Cu-LLP2A IV and undergo PET/CT over 60 minutes. Patients also undergo PET/CT between 60- and 180- minutes post-injection or at optimal imaging time point derived from cohort 1B. Patients also undergo collection of blood samples on study.
After completion of study intervention, participants in cohort 1b are followed up at 15-28 hours post-64Cu-LLP2A injection; patients in cohort 2b are followed up between 24 hours and 7 days post-64Cu-LLP2A injection.
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorFarrokh Dehdashti
