← Back to Search

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

N/A
Waitlist Available
Led By Sungheon Kim
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Patients with nasopharyngeal cancer who are scheduled for chemoradiation therapy at NYU Langone Medical Center or Bellevue hospital are eligible.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights
No Placebo-Only Group

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.

Eligible Conditions
  • Nasopharyngeal Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Magnetic Resonance Imaging

Side effects data

From 2020 Phase 1 & 2 trial • 11 Patients • NCT03665155
67%
Lymphocyte count decreased
67%
White blood cell decreased
67%
Neutrophil count decreased
33%
Dyspnea
33%
Sinus tachycardia
33%
Anemia
33%
Aspartate aminotransferase increased
33%
Blood bilirubin increased
33%
Creatinine increased
33%
Hyperglycemia
33%
Platelet count decreased
33%
Chills
33%
Allergic reaction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase I: Dose Escalation 1-5 mCi in 50mg of Antibody
Phase I: Dose Escalation 1-5 mCi in 20mg of Antibody
Phase I: Dose Escalation 1-5 mCi in 3-50mg of Antibody

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Chemo Patients with Nasopharyngeal cancerExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PET/CT scans
2016
Completed Phase 2
~40

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,060 Total Patients Enrolled
Sungheon KimPrincipal InvestigatorNYU Langone Health
~2 spots leftby Jan 2026