Pilot Imaging Study of Leukemia

Description

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.

Conditions

Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Ambiguous Lineage Leukemia or Lymphoma, Myeloma

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Study Overview

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Study Details

Study overview

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.

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

Pilot Imaging Study of Leukemia

Condition
Acute Lymphocytic Leukemia
Intervention / Treatment

-

Contacts and Locations

Washington

Children's National Health System, Washington, District of Columbia, United States, 20010

Atlanta

Emory University, Atlanta, Georgia, United States, 30322

Oklahoma City

University of Oklahoma Health Sciences Center, Oklahoma City, Oklahoma, United States, 73117

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 is higher)
  • 8. Pulse oximetry of \> 90% on room air
  • 9. Ability to undergo 18F FLT imaging without sedation
  • 10. 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).
  • 1. Patients with uncontrolled infections
  • 2. Pregnancy or lactating
  • 3. History of prior fluorothymidine allergy or intolerance.

Ages Eligible for Study

4 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Oklahoma,

Jennifer Holter, MD, PRINCIPAL_INVESTIGATOR, Stephenson Cancer Center

Study Record Dates

2027-04