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Diffusion MRI for Head and Neck Cancer

Primary Purpose

Head Cancer Neck

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PET/MRI with FDG

MRI scan without contrast

MRI with gadolinium

About this trial

This is an interventional diagnostic trial for Head Cancer Neck

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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

Sites / Locations

NYU Langone
Weill Cornell Medical College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Optimization of Techniques

: Longitudinal Monitoring

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Secondary Outcome Measures

Progression-Free Survival (PFS)

Binary indicator of whether patients showed progression-free survival at 2 years post treatment on the standard-of-care follow-up exams. PFS is the length of time that a patient lives with the disease but it does not get worse.

Full Information

NCT ID

NCT04251481

First Posted

January 8, 2020

Last Updated

May 3, 2023

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT04251481

Brief Title

Diffusion MRI for Head and Neck Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

October 16, 2019 (Actual)

Primary Completion Date

October 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

This study will investigate the t-dependency of dMRI over a range of diffusion times (30-500 ms) to determine an optimal diffusion time for treatment response assessment when only one diffusion time needs to be used, particularly in routine clinical studies. Furthermore, the data with multiple diffusion times will also be used to measure the water exchange time of cancer cells. Exchange time has been studied using Dynamic Contrast Enhanced (DCE) MRI by multiple groups including ours, and has been suggested as a marker of (ii) cellular metabolism that regulates the ATP-dependent ion channels co-transporting water molecules. The study will measure with dMRI, without using a contrast agent. The investigators also demonstrated that Intra-Voxel Incoherent Motion (IVIM) MRI metrics (pseudo diffusivity, Dp; perfusion fraction, fp), from multiple b-values at a fixed diffusion time, can be used to assess the perfusion status of tumor and they are also associated with tumor interstitial fluid pressure. The IVIM effect has been observed in various cancer types (33-39) and animal tumor models. The product fp*Dp - a quantity including both blood volume and velocity information - is considered as a parameter analogous to (iii) perfusion flow .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Head Cancer Neck

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Optimization of Techniques

Arm Type

Experimental

Arm Description

Arm Title

: Longitudinal Monitoring

Arm Type

Experimental

Arm Description

Intervention Type

Radiation

Intervention Name(s)

PET/MRI with FDG

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

MRI scan without contrast

Intervention Description

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.

Intervention Type

Radiation

Intervention Name(s)

MRI with gadolinium

Intervention Description

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.

Primary Outcome Measure Information:

Title

Intra-class Correlation (ICC)

Description

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.

Time Frame

6 weeks

Title

Intra-subject Coefficient of Variation (CV)

Description

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.

Time Frame

6 weeks

Title

Overall Response Rate (ORR)

Description

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

Time Frame

2 Years Post-Treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elcin Zan, MD

Organizational Affiliation

NYU Langone

Official's Role

Principal Investigator

Facility Information:

Facility Name

NYU Langone

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Weill Cornell Medical College

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

IPD Sharing 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.

IPD Sharing 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.

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Diffusion MRI for Head and Neck Cancer

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