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Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI

Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03656250
Enrollment
17
Registered
2018-09-04
Start date
2017-11-18
Completion date
2018-11-19
Last updated
2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasopharyngeal Cancer

Brief 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 clinical and imaging assessment of residual tumor size at each endpoint. It is hoped that preliminary data obtained from this study will be useful in planning larger studies to formally investigate the utility of GMR for detection of residual tumor and prediction of treatment response.

Interventions

DIAGNOSTIC_TESTPET/CT scans

(approximately 18 mSv/scan) and perform maximum two additional PET/MR scans; one immediately after the first stage of treatment and another one immediately after the second stage if the 3-month chemotherapy is given).

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

Inclusion criteria

* Patients with nasopharyngeal cancer who are scheduled for chemoradiation therapy at NYU Langone Medical Center or Bellevue hospital are eligible.

Exclusion criteria

* Normal MRI

Design outcomes

Primary

MeasureTime frameDescription
Glucose Metabolic Rate (GMR) Measured by PET/MRDay 1measured using a simultaneous PET/MR scanner to detect residual tumor

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026