← 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

ARM 1: Treatment-naïve HNSCC patients with metastatic lymph nodes prior to surgery or chemoradiation therapy

Must not have

Patients with GFR < 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.

History of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years post-treatment

Awards & highlights

No Placebo-Only Group

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.

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.

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 have head and neck cancer with spread to lymph nodes and haven't started treatment.

Select...

I am able to understand and agree to the study's requirements.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My kidney function is not severely reduced, and I am not on dialysis.

Select...

I have a history of seizures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years post-treatment

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Intra-class Correlation (ICC)

Intra-subject Coefficient of Variation (CV)

Overall Response Rate (ORR)

Secondary study objectives

Progression-Free Survival (PFS)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 5Eligibility criteria met