RECRUITING

Pilot Imaging Study of Leukemia

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Conditions

Acute Lymphocytic LeukemiaAcute Myeloid LeukemiaAmbiguous Lineage Leukemia or LymphomaMyelomaFLT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2023-01-19
Study Completion:2027-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03633955

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.

Ages Eligible for Study:4 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Aged 4 to 80 years
  2. 2. Evidence of high-risk hematopoietic malignancy with relapsed/refractory disease: acute lymphocytic leukemia, Acute myeloid leukemia, Ambiguous lineage leukemia, myeloma
  3. 3. Karnofsky/Lansky score of ≥ 50
  4. 4. Agree to use contraceptive measures during study protocol participation (when age appropriate)
  5. 5. Patient or parent/guardian capable of providing informed consent.
  6. 6. Ability to undergo 18F FLT imaging without sedation
  7. 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. 8. Pulse oximetry of \> 90% on room air
  9. 9. Ability to undergo 18F FLT imaging without sedation
  10. 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. 1. Patients with uncontrolled infections
  2. 2. Pregnancy or lactating
  3. 3. History of prior fluorothymidine allergy or intolerance.

Contacts and Locations

Study Contact

Heme Onc Lead Nurse
CONTACT
1-405-271-8777
SCC-IIT-Office@ouhsc.edu

Principal Investigator

Jennifer Holter, MD
PRINCIPAL_INVESTIGATOR
Stephenson Cancer Center

Study Locations (Sites)

Children's National Health System
Washington, District of Columbia, 20010
United States
Emory University
Atlanta, Georgia, 30322
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Jennifer Holter, MD, PRINCIPAL_INVESTIGATOR, Stephenson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-19
Study Completion Date2027-04

Study Record Updates

Study Start Date2023-01-19
Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

  • FLT

Additional Relevant MeSH Terms

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