This is a prospective pilot study, the primary aim of which is to determine whether the presence of 18F FLT imaging signal uptake abnormalities correlate with clinically validated evidence of hematopoietic malignant disease (e.g. MRD, molecular, flow or histology) after immunotherapy and other treatments.
Aged 4 to 80 years
Evidence of high-risk hematopoietic malignancy with relapsed/refractory disease: acute lymphocytic leukemia, Acute myeloid leukemia, Ambiguous lineage leukemia, myeloma
Karnofsky/Lansky score of ≥ 50
Agree to use contraceptive measures during study protocol participation (when age appropriate)
Patients with uncontrolled infections
Pregnancy or lactating
History of prior fluorothymidine allergy or intolerance.
Parallel
FLT
DrugF18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies.
Proportion of 18F FLT signal uptake abnormalities with clinical pathology reports for determining the evidence of hematopoietic disease.
A proportion of patients will undergo 18F FLT imaging before and after immunotherapy or standard therapy for hematopoietic malignant disease. To detect changes in the progression of hematopoietic disease 18F FLT image scans collected pre-treatment (baseline) and post-treatment (follow-up) of patient visit at OUHSC will be compared with clinically validated evidence of hematopoietic malignant disease collected using MRD, molecular, flow and histology techniques.
A proportion of 18F FLT uptake in a standard region of interest in marrow to objectively identify disease status in patient with hematopoietic cancers.
For proportion of patient the analyses will be compared between two Arms of disease cohort. Arm A to include patients who received immunotherapy (immunotherapy protocol co-enrollment or other immunotherapy), and Arm B: those who received other non-immune therapies to treat their cancers (excludes HSCT). For marrow disease, the intra-medullary pattern and standard unit of uptake (SUV) will be compared pre- and post-treatment between patients in remission clinically versus those with greater disease burden, to determine if 18F FLT uptake correlates with identified clinical relapse.
Mean differences of 18F FLT uptake to determine extramedullary disease.
For proportion of patient undergoing 18F FLT scan, the extramedullary disease will be identified by comparing the SUV and size of lesions pre- and post-treatment. The comparisons will be done in two arms of disease cohort Arm A, i.e., to include patients who received immunotherapy (immunotherapy protocol co-enrollment or other immunotherapy), and Arm B: those who received other non-immune therapies to treat their cancers (excludes HSCT).
Click on the lead sponsor to view all of their trials.
University of Oklahoma
Lead sponsor
Emory University
Collaborator
