ACTIVE_NOT_RECRUITING

Diffusion MRI for Head and Neck Cancer

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Assessment of the Role of Diffusion MRI Changes During Chemoradiation Treatment of Head and Neck Cancer

Quick Facts

Study Start:2019-10-16
Study Completion:2026-04-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04251481

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Treatment-naïve HNSCC patients with metastatic lymph nodes prior to surgery or chemoradiation therapy
  2. * Age 18 or older
  3. * Subjects without capacity to consent will not be enrolled.
  4. * Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.
  5. * Treatment-naïve HNSCC patients with metastatic lymph nodes who will undergo standard-of-care chemoradiation therapy
  6. * Age 18 or older
  7. * Subjects without capacity to consent will not be enrolled.
  8. * Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.
  1. * Subjects who have the following contraindications to MRI:
  2. * Electrical implants such as cardiac pacemakers or perfusion pumps
  3. * 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
  4. * History of seizures
  5. * Patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
  6. * Subjects who are pregnant

Contacts and Locations

Principal Investigator

Elcin Zan, MD
PRINCIPAL_INVESTIGATOR
NYU Langone

Study Locations (Sites)

NYU Langone
New York, New York, 10016
United States
Weill Cornell Medical College
New York, New York, 10065
United States

Collaborators and Investigators

Sponsor: NYU Langone Health

  • Elcin Zan, MD, PRINCIPAL_INVESTIGATOR, NYU Langone

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-10-16
Study Completion Date2026-04-30

Study Record Updates

Study Start Date2019-10-16
Study Completion Date2026-04-30

Terms related to this study

Additional Relevant MeSH Terms

  • Head Cancer Neck