RecruitingPhase 1NCT03633955
Pilot Imaging Study of Leukemia
Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging
Sponsor
University of Oklahoma
Enrollment
60 participants
Start Date
Jan 19, 2023
Study Type
INTERVENTIONAL
Conditions
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.
Eligibility
Min Age: 4 YearsMax Age: 80 Years
Inclusion Criteria10
- 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).
Exclusion Criteria3
- Patients with uncontrolled infections
- Pregnancy or lactating
- History of prior fluorothymidine allergy or intolerance.
Interventions
DRUGFLT
F18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies.
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT03633955
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