Diffusion MRI for Head and Neck Cancer

NCT04251481 | Active Not Recruiting DMC

• 1 other identifier: 18-01454
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed study is to investigate the feasibility of using quantitative diffusion MRI (dMRI) methods for accurate and comprehensive assessment of treatment response. dMRI is a powerful tool to probe treatment-induced change in tumors. It is a unique in vivo imaging technique sensitive to cellular microstructures at the scale of water diffusion length on the order of a few microns. Previous studies have shown that both diffusion coefficient D and diffusional kurtosis coefficient K are promising imaging markers of (i) cell viability which can be used for evaluation of early treatment response. However, it is often underappreciated that these dMRI metrics are not fixed constants, but rather functions of the diffusion time t, D(t) and K(t); their t-dependency is determined by tissue properties, such as cell size and membrane permeability of tissue. D(t) and K(t) of tumors can vary substantially depending on t in the range of diffusion times (30-100 ms) typically used in clinical scan.

Conditions

Head Cancer Neck

Outcome Measures

Primary Outcomes (3)

• Intra-class Correlation (ICC)

  Estimated components from a random effects model in each dMRI measure will be used to compute intra-class correlation as estimates of repeatability of each measure.

  6 weeks

• Intra-subject Coefficient of Variation (CV)

  Estimated components from a random effects model in each dMRI measure will be used to compute intra-subject coefficient of variation as estimates of repeatability of each measure.

  6 weeks

• Overall Response Rate (ORR)

  Binary classification of treatment response as complete response (CR) versus partial response (PR) for participants at the end of the chemoradiation therapy assessed by clinical/radiological reports. CR will include the cases with complete disappearance of any clinically detectable tumor mass, while PR will include cases with stable disease and progressive disease.

  6 weeks

Secondary Outcomes (1)

• Progression-Free Survival (PFS)

  2 Years Post-Treatment

Study Arms (2)

Optimization of Techniques

EXPERIMENTAL

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.

Radiation: PET/MRI with FDG; Radiation: MRI scan without contrast

: Longitudinal Monitoring

EXPERIMENTAL

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.

Radiation: MRI scan without contrast; Radiation: MRI with gadolinium

Interventions

PET/MRI with FDG RADIATION

For the PET/MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for both the MRI and PET portions of the examination. The dye for the PET portion will be 18F-fluorodeoxyglucose (FDG). FDG is an FDA-approved radioactive substance (isotope) that contains chemicals that can be traced by PET/MRI. The dye for the MRI portion will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.

Optimization of Techniques

MRI scan without contrast RADIATION

MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner to scan the neck ; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.

: Longitudinal Monitoring; Optimization of Techniques

MRI with gadolinium RADIATION

For the MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for MR scans. The dye for the MRI will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.

: Longitudinal Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ARM 1
• Treatment-naïve HNSCC patients with metastatic lymph nodes prior to surgery or chemoradiation therapy
• Age 18 or older
• Subjects without capacity to consent will not be enrolled.
• Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.
• ARM 2
• Treatment-naïve HNSCC patients with metastatic lymph nodes who will undergo standard-of-care chemoradiation therapy
• Age 18 or older
• Subjects without capacity to consent will not be enrolled.
• Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.

You may not qualify if:

• Subjects who have the following contraindications to MRI:
• 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
• History of seizures
• Patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
• Subjects who are pregnant

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (2)

NYU Langone

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy; Contrast Media; Gadolinium

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Officials

• Elcin Zan, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: February 5, 2020
• Study Start: October 16, 2019
• Primary Completion: April 30, 2026
• Study Completion: April 30, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data. Upon reasonable request. Requests should be directed to gene.kim@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (2)