NCT02392429Active, not recruitingPhase 2
FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia
Early Assessment of Treatment Response in AML Using FLT PET/CT Imaging
Source: ClinicalTrials.gov · Last updated 23 Sept 2026
Brief summary (registry, in English)
This phase II trial studies fluorothymidine F 18 (FLT) positron emission tomography (PET)/computed tomography (CT) in measuring response in patients with previously untreated acute myeloid leukemia. FLT is a radioactive substance that may "light up" where cancer is in the body. FLT is injected into the blood and builds up in cells that are dividing, including cancer cells. Diagnostic procedures, such as PET/CT, may help measure a patient's response to earlier treatment.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 18 Mar 2015
- Start date
- 20 Apr 2016
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- National Cancer Institute (NCI)
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT02392429
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 87
- From 20 Apr 2016 to the primary completion date, 31 Dec 2023
- 11 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- Age ≥ 18 years
- Patients must have previously untreated AML and be candidates for intensive induction chemotherapy; patients are allowed to have had prior hydroxyurea
- Patients must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21)
- Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3 (restricted to ECOG performance status \[PS\] 0-2 if age \> 70 years)
- Patients must have left ventricular ejection fraction (LVEF) \> 45% or within institutional normal limits
- Patients must be able to lie still for a 1.5 hour PET scan
- Patient must NOT have a history of allergic reaction attributable to compounds of similar chemical or biologic composition to 18F-fluorothymidine
- Patient must NOT weigh more than the maximum weight limit for the PET/CT table for the scanner(s) to be used at each center
- The patient is participating in the trial at an institution which has agreed to perform the imaging research studies, completed the ECOG-American College of Radiology Imaging Network (ACRIN) defined scanner qualification procedures and received ECOG-ACRIN approval as outlined
- Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to registration to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (11)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UNC Lineberger Comprehensive Cancer Center Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| UT Southwestern/Simmons Cancer Center-Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Wisconsin Carbone Cancer Center - University Hospital Coordinator of this site? Confirm its status | Madison | United States | Unknown status |
| Vanderbilt University/Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Oklahoma Health Sciences Center Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
| Fox Chase Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| University of Pennsylvania/Abramson Cancer Center Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Mayo Clinic in Rochester Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
| Huntsman Cancer Institute/University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| Washington University School of Medicine Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.