Study on Using FLT PET/CT Scans to Measure Treatment Response in Patients with Untreated Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT02392429
This clinical trial is exploring how well a special type of scan, called FLT PET/CT, can measure how patients with untreated acute myeloid leukemia (AML) respond to their initial chemotherapy treatment.
Patient Parameters
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Program Overview
This study is testing a scanning method called FLT PET/CT to see how well it can show the response of patients with untreated acute myeloid leukemia (AML) to their first round of chemotherapy. FLT is a radioactive substance that highlights areas in the body where cancer cells are actively dividing. By using this scan, doctors hope to better understand how well the treatment is working.
Description
The main goal of this study is to see if FLT PET/CT scans can accurately predict when patients with AML achieve complete remission after chemotherapy. Researchers will also look at how well these scans can detect complete remission and how they relate to other tests that measure minimal residual disease (MRD) and patient survival rates.
Patients in the study will receive chemotherapy drugs, anthracycline and cytarabine, through an IV for up to two courses. They will undergo FLT PET/CT scans around the time of their bone marrow biopsy, which happens between days 10-17 after starting treatment. An optional scan may be done before starting chemotherapy if it doesn't delay treatment. Bone marrow and blood samples will also be collected during the study.
After the study, patients will have follow-up visits between days 28-35 and continue to be monitored for up to a year after the study ends.
Eligibility Criteria
Inclusion Criteria
- Be 18 years or older.
- Have a diagnosis of untreated acute myeloid leukemia (AML) and be eligible for intensive chemotherapy.
- Have not been diagnosed with acute promyelocytic leukemia (APL) or have specific genetic markers.
- Have a performance status score of 0-3, or 0-2 if over 70 years old, indicating general health and ability to perform daily activities.
- Have a heart function test showing an ejection fraction over 45% or within normal limits.
- Be able to lie still for a 1.5-hour PET scan.
- Not have allergies to similar compounds as the FLT used in the scan.
- Not exceed the weight limit for the PET/CT scanner.
- Participate at a trial site approved to perform the imaging studies.
- Women must not be pregnant or breastfeeding and must have a negative pregnancy test if of childbearing potential.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic in Rochester | 55905 | Rochester | Minnesota |
| Washington University School of Medicine | 63110 | St Louis | Missouri |
| Mount Sinai Hospital | 10029 | New York | New York |
| UNC Lineberger Comprehensive Cancer Center | 27599 | Chapel Hill | North Carolina |
| University of Oklahoma Health Sciences Center | 73104 | Oklahoma City | Oklahoma |
| University of Pennsylvania/Abramson Cancer Center | 19104 | Philadelphia | Pennsylvania |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
| Vanderbilt University/Ingram Cancer Center | 37232 | Nashville | Tennessee |
| UT Southwestern/Simmons Cancer Center-Dallas | 75390 | Dallas | Texas |
| Huntsman Cancer Institute/University of Utah | 84112 | Salt Lake City | Utah |
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