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

What's the purpose of this trial?

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.

This trial is currently open and accepting patients.

What will happen during the trial?

You may be able to join this trial if you:

The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.

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.

Additional Trial Information

Phase 1

Enrollment: 60 patients (estimated)

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Trial Locations

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View all clinical trial locations sorted by state.

Georgia

Winship Cancer Institute Emory University

Atlanta, GA

Not Yet Accepting

Oklahoma

University of Oklahoma Health Sciences Center

Oklahoma City, OK

Open and Accepting
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