Pilot Imaging Study of Leukemia
Recruiting now · Phase 1
Conditions studied: Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Ambiguous Lineage Leukemia or Lymphoma, Myeloma
In brief
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.
Key facts
- Study ID
- NCT03633955
- Run by
- University of Oklahoma
- People needed
- 60
- Starts
- 2023-01-19
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2026-04-23
Who can join
Age: 4 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
- Patient or parent/guardian capable of providing informed consent.
- Ability to undergo 18F FLT imaging without sedation
- 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 immune therapy with co-enrollment on a separate protocol or other immunotherapy) and Arm B, those who received other non-immune therapies to treat their cancers (excludes HSCT but includes chemotherapy or non-HSCT radiotherapy).
You may not qualify if…
- Patients with uncontrolled infections
- Pregnancy or lactating
- History of prior fluorothymidine allergy or intolerance.
Where it is running
- University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States (enrolling)
- Children's National Health System — Washington D.C., District of Columbia, United States
- Emory University — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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