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Back|NCT03633955Recruiting
Official Title

Multi-institutional Prospective Pilot Study of Radiology Evaluation of Acute Leukemia Infiltration analyZed by Experimental Imaging

Phase
Phase 1
Sponsor
University of Oklahoma
Enrollment
60
Timeline
Jan 2023 → Apr 2028
About This Study

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 Criteria

Inclusion Criteria

  • 1Aged 4 to 80 years
  • 2Evidence of high-risk hematopoietic malignancy with relapsed/refractory disease: acute lymphocytic leukemia, Acute myeloid leukemia, Ambiguous lineage leukemia, myeloma
  • 3Karnofsky/Lansky score of ≥ 50
  • 4Agree to use contraceptive measures during study protocol participation (when age appropriate)
  • 5Patient or parent/guardian capable of providing informed consent.
  • 6Ability to undergo 18F FLT imaging without sedation
  • 7Bilirubin \< 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)
  • 8Pulse oximetry of \> 90% on room air
  • 9Ability to undergo 18F FLT imaging without sedation
  • 10Anticipated 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 Criteria

  • 1Patients with uncontrolled infections
  • 2Pregnancy or lactating
  • 3History of prior fluorothymidine allergy or intolerance.

Locations

3 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

Kirsten M Williams, MD

Children's National Health System

Washington D.C., District of Columbia 20010

Withdrawn

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma 73117

Recruiting

Jennifer Holter Chakrabarty, MD

jholter2@ouhsc.edu405-271-4022
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →