Pilot Imaging Study of Leukemia

• Status: Not yet recruiting
• Trial end date: 2025-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Oklahoma
• Collaborator: Emory University

Criteria

Inclusion Criteria:

• Aged 4 to 80 years

• Evidence of high risk hematopoietic malignancy with relapsed/refractory disease and/or high risk for relapse.

o Acute lymphocytic leukemia, Acute myeloid leukemia, Chronic myelogenous leukemia, Ambiguous lineage leukemia or lymphoma, or myelodysplastic syndrome

• Karnofsky/Lansky score of ≥ 50

• Agree to use contraceptive measures during study protocol participation (when age appropriate)

• Patient or parent/guardian capable of providing informed consent.

• Bilirubin < 2.5 mg/dL, AST/ALT <5x upper limit of normal, Serum creatinine < 1.0 or 2x the upper limit of normal (whichever is higher)

• Pulse oximetry of > 90% on room air

• Ability to undergo 18F FLT imaging without sedation

• Anticipated immunotherapy (Arm A to include patients who received immunotherapy) and Arm B, those who received other non-immune therapies to treat their cancers (excludes HSCT but includes chemotherapy or non-HSCT radiotherapy).

Exclusion Criteria:

• Patients with uncontrolled infections

• Pregnancy or lactating

• History of prior fluorothymidine allergy or intolerance