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NCT02392429 · ClinicalTrials.gov registry record · Phase 2
FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia
A Phase 2 study of Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
- 11
- Study locations
NCT02392429: Active Phase 2 study of Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
NCT02392429 is a Phase 2 study of Acute Myeloid Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 87 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (25% lower). The trial reports 11 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02392429, a Phase 2 study of Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
- 11
- Study locations
Study Summary
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.
Primary Outcome
Three imaging parameters (standardized uptake value \[SUV\]mean, SUVmax, heterogeneity of FLT uptake \[SUVhetero\]) will be measured from an FLT PET/CT scan and SUVmax will be the primary endpoint. Higher values of SUVmax assume to indicate a non-response the therapy and a cut point of 7 (SUVmax \>7) will be used as the threshold indicating a negative scan. The binomial proportion of negative predictive value (NPV) and the corresponding exact confidence intervals will be calculated. In addition,
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- PROCEDURE Computed Tomography
- DRUG Chemotherapy
Study Locations (11)
Pennsylvania
- University of Pennsylvania/Abramson Cancer Center - Philadelphia
- Fox Chase Cancer Center - Philadelphia
Minnesota
- Mayo Clinic in Rochester - Rochester
Missouri
- Washington University School of Medicine - St Louis
New York
- Mount Sinai Hospital - New York
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Tennessee
- Vanderbilt University/Ingram Cancer Center - Nashville
Texas
- UT Southwestern/Simmons Cancer Center-Dallas - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2016-04-20 |
| Est. Completion | 2027-02-13 |
| Phase | Phase 2 |
What the registry record for NCT02392429 still lists
NCT02392429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (25% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT02392429 lists 11 locations in 10 states (Pennsylvania, Minnesota, Missouri).
Frequently Asked Questions
What is clinical trial NCT02392429 about?
NCT02392429 is a clinical study titled "FLT PET/CT in Measuring Response in Patients With Previously Untreated Acute Myeloid Leukemia". 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 ...
What is the current status of trial NCT02392429?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2016-04-20. Estimated completion is 2027-02-13.
What conditions does trial NCT02392429 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT02392429?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Computed Tomography (PROCEDURE), Chemotherapy (DRUG).
Who is sponsoring clinical trial NCT02392429?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02392429 being conducted?
This trial has 11 study locations across Minnesota, Missouri, New York, North Carolina, Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02392429's enrollment target sits among peer trials
87 91st of 306 higher than 216 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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