← Back to Search

Diffusion MRI for Head and Neck Cancer

N/A
Waitlist Available
Led By Elcin Zan, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 or older
Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post-treatment
Awards & highlights

Study Summary

This trial is investigating whether or not using quantitative diffusion MRI (dMRI) is a feasible way to get an accurate and comprehensive assessment of treatment response in tumors.

Who is the study for?
This trial is for adults with head and neck cancers who haven't started treatment. They must understand the study's key points, which will be explained in their language if needed. Excluded are those with very poor kidney function, pregnant women, people with certain metal implants or electrical devices in their body, or a history of seizures.Check my eligibility
What is being tested?
The study tests how well diffusion MRI (dMRI), including PET/MRI with FDG and MRI with gadolinium contrast, can assess cancer treatment response by measuring changes at a microscopic level within tumors.See study design
What are the potential side effects?
Potential side effects may include discomfort from lying still during scans and reactions to gadolinium contrast like nausea or itching. There's also a small risk of kidney problems from the contrast agent.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.
Select...
I understand the key details of the trial, or will use a translator if needed.
Select...
I have head and neck cancer with spread to lymph nodes and haven't started treatment.
Select...
I am 18 years old or older.
Select...
I am able to understand and give consent for my participation.
Select...
I have HNSCC with metastatic lymph nodes and haven't received any treatment yet.
Select...
I am able to understand and agree to the study's requirements.
Select...
I understand the key elements of the trial, or will use a translator.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Intra-class Correlation (ICC)
Intra-subject Coefficient of Variation (CV)
Overall Response Rate (ORR)
Secondary outcome measures
Progression-Free Survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Optimization of TechniquesExperimental Treatment2 Interventions
To optimize the diffusion MRI methods for assessment of cell viability, metabolism and perfusion in head and neck cancer. There will be 24 subjects enrolled for 2 year duration. Treatment-naïve patients with cervical metastatic lymph nodes (diameter > 10 mm) of HNSCC will be recruited to have one research PET/MR scan (including dMRI) and one dMRI-only scan within three days prior to treatment. These data will be used to optimize the dMRI method and assess the repeatability.
Group II: : Longitudinal MonitoringExperimental Treatment2 Interventions
To assess the feasibility of using diffusion MRI metrics at early stages of treatment for prediction of treatment response in head and neck cancer patients undergoing standard-of-care chemoradiation therapy. There will be 36 subjects enrolled for 3 year duration. The study will do bi-weekly measurement to monitor tumor response longitudinally. This study will be restricted to treatment-naïve patients who present pathologically confirmed HNSCC with metastatic lymph nodes and who are scheduled to receive standard care of radiation therapy with concurrent chemotherapy. The patients enrolled in this arm of the study will have 4 dMRI scans. The imaging data for each patient will be the proposed dMRI measures at the baseline and their changes at each follow-up time period. DCE-MRI will be included in the baseline scan for tumor delination as in standard-of-care cancer imaging and to compare with the proposed dMRI method.

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,358 Previous Clinical Trials
816,805 Total Patients Enrolled
Elcin Zan, MDPrincipal InvestigatorNYU Langone

Media Library

PET/MRI with FDG Clinical Trial Eligibility Overview. Trial Name: NCT04251481 — N/A
Head and Neck Cancers Research Study Groups: : Longitudinal Monitoring, Optimization of Techniques
Head and Neck Cancers Clinical Trial 2023: PET/MRI with FDG Highlights & Side Effects. Trial Name: NCT04251481 — N/A
PET/MRI with FDG 2023 Treatment Timeline for Medical Study. Trial Name: NCT04251481 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently being accepted for participation in this experiment?

"This study, which was initially listed on October 16th 2019 and last updated on June 3rd 2022, is not currently accepting participants. Nevertheless, 395 other trials are actively recruiting patients at this moment in time."

Answered by AI
~1 spots leftby Oct 2024