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NCT03656250 · ClinicalTrials.gov registry record
Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI
A clinical trial of Nasopharyngeal Cancer, sponsored by NYU Langone Health.
- Completed
- Registry status
- 17
- Enrollment target
- 1
- Study location
NCT03656250 is a study of Nasopharyngeal Cancer that has completed, run by NYU Langone Health. The registered enrollment target is 17 participants, below the 182-participant average among 4 other Nasopharyngeal Cancer trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03656250, a study of Nasopharyngeal Cancer, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- 17 participants
- Enrollment target
- 1
- Study location
Study Summary
The overarching goal of this study is to develop PET/MR techniques for accurate assessment of treatment response during and immediately after chemoradiation therapy. The central hypothesis is that the GMR measured using a simultaneous PET/MR scanner can more accurately detect residual tumor than conventional SUV measures from PET alone. It is important to note that SUV depends on both tumor metabolic rate and tracer delivery, which makes the interpretation of SUV challenging. For instance, inflammatory tissue can have high SUV due to increased vascularity and vascular permeability and cannot be easily differentiated from tumor based on the SUV. Investigators hypothesize that inflammatory tissue will have lower GMR than residual tumor that contain highly proliferating cells with increased expression of glucose transporters (GLUT). Measuring GMR accurately will improve the specificity of PET while maintaining the high sensitivity of PET for detection of residual tumor. In order to test our hypothesis, investigators propose to conduct dynamic PET and MRI scans with NPC patients who are undergoing a conventional two-stage chemoradiation therapy at our institution; the first stage for 7-week chemoradiation therapy followed by the second stage for 3-month chemotherapy. A combination of PET/CT and nasopharynx MRI is currently obtained before the initiation of treatment and 3 months after completion of treatment to assess treatment response. This study proposes to introduce PET/MR scans at the time of these exams (scan #1 for pre-treatment \& scan #4 for 3 months after completion) and to add two additional PET/MR scans in between them; one immediately after the first stage of treatment (scan #2) and another one immediately after the second stage (scan #3). A primary clinical endpoint of this study is the treatment response assessed at 3 months after completion of treatment. A secondary endpoint is 6 month follow-up exam. Complete responder will be determined based on clini
Conditions Studied
Interventions
- DIAGNOSTIC_TEST PET/CT scans
Study Locations (1)
New York
- New York University School of Medicine - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-11-18 |
| Est. Completion | 2018-11-19 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03656250
The ClinicalTrials.gov registry entry for NCT03656250 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 182-participant average among 4 other Nasopharyngeal Cancer trials with a reported enrollment target (91% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Nasopharyngeal Cancer appearing as the primary indexed condition, and to 1 intervention - of which PET/CT scans is the first listed.
NCT03656250 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT03656250 about?
NCT03656250 is a clinical study titled "Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI". The overarching goal of this study is to develop PET/MR techniques for accurate assessment of treatment response during and immediately after chemoradiation therapy. The central hypothesis is that the GMR measured using a simultaneous PET/MR scanner can more accurately detect residual tumor than con...
What is the current status of trial NCT03656250?
This trial is currently completed. The enrollment target is 17 participants. The study started on 2017-11-18. Estimated completion is 2018-11-19.
What conditions does trial NCT03656250 study?
This clinical trial studies the following conditions: Nasopharyngeal Cancer.
What interventions are being tested in trial NCT03656250?
The interventions under investigation include: PET/CT scans (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03656250?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03656250 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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