Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging

What this Trial Is About

Researchers are evaluating whether 18F FLT imaging can detect the presence and extent of hematopoietic malignant diseases, such as acute leukemia and myeloma, after immunotherapy or other treatments. This prospective pilot study aims to correlate imaging abnormalities with clinically validated evidence of disease, including molecular and histological findings. It includes patients with high-risk acute leukemia or myeloma, some of whom may have undergone stem cell transplantation. The study is sponsored by the University of Oklahoma and focuses on individuals aged 4 to 80 years with relapsed or refractory disease and a Karnofsky/Lansky score of 50 or higher. Participants will be divided into two main cohorts based on their diagnosis: high-risk acute leukemia or myeloma. Each cohort has two arms: one receiving immunotherapy and the other receiving standard therapy, such as chemotherapy or non-stem cell transplant radiotherapy. All patients will undergo 18F FLT PET/CT scans before starting their therapy and again approximately 28 days after treatment. This imaging helps assess disease burden both subjectively and through measurable uptake values. Follow-up visits will be conducted weekly until the follow-up scan and a final evaluation one year after the start of therapy. During the study, participants will have regular assessments, including 18F FLT imaging without sedation, and monitoring of liver and kidney function, oxygen levels, and overall health status. Researchers will measure the proportion of 18F FLT signal uptake abnormalities compared to clinical pathology reports to evaluate disease status, including extramedullary involvement. The study will track patient outcomes up to one year post-treatment, with close observation for any adverse effects or disease progression throughout the follow-up period.

Pilot Imaging Study of Leukemia