This phase I trial tests the safety, side effects, and how well the 18F FLT positron emission tomography (PET) scan detects cancer in patients with acute leukemia that have come back (recurrent) or have not respond to treatment (refractory). 18F FLT is an imaging agent that is taken up by cancer cells and may identify leukemia disease. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of a tracer to determine how well tissues and organs are working. Undergoing 18F FLT PET scans may improve cancer diagnosis and determine whether cancer has responded to treatment.
Additional locations may be listed on ClinicalTrials.gov for NCT03633955.
Locations matching your search criteria
United States
Oklahoma
Oklahoma City
University of Oklahoma Health Sciences CenterStatus: Active
Contact: Jennifer Lin Holter-Chakrabarty
Phone: 405-271-4022ext48397
PRIMARY OBJECTIVES:
I. Evaluate whether fluorothymidine F-18 (18F FLT) signal uptake abnormalities correlate with clinically validated evidence of hematopoietic malignant disease (e.g. minimal residual disease [MRD], molecular, flow or histology) after immunotherapy and other treatments.
II. Evaluate whether 18F FLT uptake objectively identifies disease status in patients with high risk hematopoietic cancers before and after therapy using standard region of interest measurements.
SECONDARY OBJECTIVES:
I. Evaluate whether 18F FLT uptake objectively identifies disease status in patients with high risk hematopoietic malignancy before and after therapy computer-generated region of interest assessments.
II. Evaluate whether 18F FLT uptake identifies extramedullary disease.
III. Confirm that 18F FLT imaging is well-tolerated in patients with hematopoietic cancers undergoing therapies, including those receiving immunotherapy (e.g. Immune therapy with co-enrollment).
EXPLORATORY OBJECTIVES:
I. Explore whether 18F FLT imaging is less painful and anxiety provoking than bone marrow tests using patient reported outcomes.
II. Explore whether 18F FLT imaging response correlates with patient reported outcomes.
III. Explore whether 18F FLT uptake correlates with other biomarker studies of relapse, e.g. WT1.
IV. Explore whether 18F FLT shows for evidence of other co-incident diseases that could aid clinical care (e.g. cytomegalovirus [CMV] pneumonitis).
OUTLINE:
Patients receive 18F FLT intravenously (IV) and undergo PET scan pre and post therapy on study. Patients undergo blood specimen collections and complete questionnaires throughout study.
Lead OrganizationUniversity of Oklahoma Health Sciences Center
Principal InvestigatorJennifer Lin Holter-Chakrabarty