RightFit
RecruitingPhase 1

Pilot Imaging Study of Leukemia

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
4 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether an imaging scan called 18F FLT can find signs of blood cancer that match other cancer tests after treatment. It is for people ages 4 to 80 with certain high-risk blood cancers that have come back or have not responded to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 4 to 80 years old.
  • Have high-risk acute lymphocytic leukemia, acute myeloid leukemia, ambiguous lineage leukemia, or myeloma that has come back or has not responded to treatment.
  • Have a score of at least 50 on the Karnofsky or Lansky scale, which measures how well you can do daily activities.
  • Agree to use birth control during the study, when age appropriate. You or your parent or guardian must be able to give informed consent.
  • Be able to have the 18F FLT scan without medicine to make you sleepy or calm.
  • Meet blood test limits: bilirubin below 2.5 mg/dL; AST and ALT liver tests below 5 times the normal upper limit; and creatinine, a kidney test, below 1.0 or twice the normal upper limit, whichever is higher.
  • Have a blood oxygen level above 90% while breathing room air.
  • Have planned or received immune-based cancer treatment for Arm A, or received other cancer treatment for Arm B. Arm B includes chemotherapy or radiation but not a blood-forming stem cell transplant or radiation used with one.

Who can't join

  • Have an infection that is not under control.
  • Be pregnant or breastfeeding.
  • Have had an allergy to fluorothymidine, the scan tracer, or been unable to tolerate it.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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). Exclusion Criteria: 1. Patients with uncontrolled infections 2. Pregnancy or lactating 3. History of prior fluorothymidine allergy or intolerance.

Study sites (3)

DC

GA

  • Emory University · Atlanta, GA 30322Kirsten M Williams, MD · Study contactKirsten M Williams, MD · Principal investigatorMore trials in Atlanta

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