Brief Title
Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI
Official Title
Assessment of Treatment Response of Nasopharyngeal Cancer Using Simultaneous 18F-FDG-PET and MRI
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.
Study Type
Observational
Primary Outcome
Glucose Metabolic Rate (GMR) Measured by PET/MR
Condition
Nasopharyngeal Cancer
Intervention
PET/CT scans
Study Arms / Comparison Groups
Chemo Patients with Nasopharyngeal cancer
Description: The standard chemoradiation treatment (total 7000 cGy in 35 fractions at 200 cGy/fraction) for 7 weeks with 3 cycles of chemo followed by 3-month chemotherapy.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Diagnostic Test
Estimated Enrollment
17
Start Date
November 18, 2017
Completion Date
November 19, 2018
Primary Completion Date
November 19, 2018
Eligibility Criteria
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 exclusion criteria will apply, including those on the following list. A
standard MRI safety form will be used to identify potential conditions warranting
exclusion.
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial
heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the
eye, or steel implants
- Ferromagnetic objects such as jewelry or metal clips in clothing
- Claustrophobia
- History of seizures
- Diabetes
In addition, patients with GFR < 15 ml/min/1.73m2 or who are on dialysis will be excluded
from the study.
Gender
All
Ages
18 Years - 99 Years
Accepts Healthy Volunteers
No
Contacts
Sungheon Kim, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT03656250
Organization ID
15-00846
Responsible Party
Sponsor
Study Sponsor
NYU Langone Health
Study Sponsor
Sungheon Kim, Principal Investigator, NYU Langone Health
Verification Date
October 2020