Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging
University of Oklahoma
Summary
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.
Description
This prospective trial is designed to evaluate whether investigational 18F FLT imaging can identify the burden of hematopoietic disease both subjectively (by pattern of hematopoiesis in medullary spaces) and objectively (by SUV determination). Patients undergoing therapy for treatment of high-risk acute leukemia or myeloma will be eligible for this study. Patients may or may not have undergone myeloablative hematopoietic stem cell transplantation. Two cohorts will be accrued: patients with high risk acute leukemia and patients with myeloma. In each cohort, patients will be accrued under two a…
Eligibility
- Age range
- 4–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Aged 4 to 80 years 2. Evidence of high-risk hematopoietic malignancy with relapsed/refractory disease: acute lymphocytic leukemia, Acute myeloid leukemia, Ambiguous lineage leukemia, myeloma 3. Karnofsky/Lansky score of ≥ 50 4. Agree to use contraceptive measures during study protocol participation (when age appropriate) 5. Patient or parent/guardian capable of providing informed consent. 6. Ability to undergo 18F FLT imaging without sedation 7. Bilirubin \< 2.5 mg/dL, AST/ALT \<5x upper limit of normal, Serum creatinine \< 1.0 or 2x the upper limit of normal (whichever…
Interventions
- DrugFLT
F18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies.
Locations (3)
- Children's National Health SystemWashington D.C., District of Columbia
- Emory UniversityAtlanta, Georgia
- University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma