Pilot Imaging Study of Leukemia

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
University of Oklahoma
Study ID
NCT03633955
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
4 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • FLT — DRUG
    F18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies.

Study Details

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 Dates

Start date
Jan 19, 2023
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2029

Study Design

Enrollment
60 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Standard therapy - Acute leukemia cohort
    The Arm will accrue patients receiving standard therapy from the high-risk acute leukemia cohort (18 patients).
  • Experimental: Immunotherapy - Acute leukemia cohort
    The Arm will accrue patients receiving immunotherapy from the high-risk acute leukemia cohort (18 patients).
  • Active Comparator: Standard therapy - Myeloma cohort
    The Arm will accrue patients receiving standard therapy from the myeloma cohort (9 patients).
  • Experimental: Immunotherapy - Myeloma cohort
    The Arm will accrue patients receiving immunotherapy from the myeloma cohort (9 patients).

Primary Outcome Measure

Proportion of 18F FLT signal uptake abnormalities with clinical pathology reports for determining the evidence of hematopoietic disease. [ Time Frame: day -7 to 10 days pre-treatment and +28 (+/- 3 days) post-treatment ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's National Health SystemWashington D.C.District of Columbia20010-
Emory UniversityAtlantaGeorgia30322
Kirsten M Williams, MD
Kirsten M Williams, MD (PRINCIPAL_INVESTIGATOR)
University of Oklahoma Health Sciences CenterOklahoma CityOklahoma73117
Jennifer Holter Chakrabarty, MD
[email protected]
405-271-4022

Find similar trials in Washington D.C., DC

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By specialty
OncologyBlood cancer
By research site
Children's National Health System· Washington D.C., DCEmory University· Atlanta, GAUniversity of Oklahoma Health Sciences Center· Oklahoma City, OK

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