Dynamic Contrast Enhanced MRI (DCE-MRI) Diffusion Weighted MRI (DW-MRI) and Magnetic Resonance Spectroscopy (MRS) of Head and Neck Tumors

NCT ID: NCT00581906

Last Updated: 2025-07-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 272 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-02-28
• Study Completion Date: 2026-02-28

Brief Summary

Magnetic resonance imaging (MRI) is a diagnostic study that makes pictures of organs of the body using magnetic field and radio frequency pulses that can not be felt. Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) uses faster imaging and contrast material (a substance used to make specific organs, blood vessels, or tumors easier to see) that is given by vein. Diffusion weighted magnetic resonance imaging (DW-MRI) allows to measure the motion of water around the cells in the tumor. Proton magnetic resonance spectroscopy (MRS) obtains chemical information from the tumor. During MRS, signals are detected from the chemicals (spectroscopy) naturally present in your tumor using radio waves. DCE-MRI, DW-MRI and MRS give extra information which is not available with the regular MRI. The regular MRI only shows pictures of the tumor while the DCE-MRI also gives information about the blood vessels of the tumor. DW-MRI provides information related to the state of the tumor tissue with regards to the quality or condition of cells present in it and MRS gives information about the chemical makeup of the tumor.

The purpose of this study is to see whether DCE-MRI, DW-MRI and MRS done before treatment can predict which patients will do well with either surgery or chemo-radiation therapy. This study will also see if DCE-MRI, DW-MRI and MRS done early in treatment can tell if the therapy is working.

Conditions

Head and Neck Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

pts undergoing surgery or chemo-radiation treatment

DCE-MRI, DW-MRI and MRS

Intervention Type: RADIATION

Pts undergo DCE-MRI, DW-MRI or 1\^H-MRS studies on either the 1.5T scanner or the 3T MRI scanners. Patients will be grouped based on their treatment: group one will include pts who undergo surgery (we will no longer accrue pts in this group) \& group two will include pts who undergo chemoradiation therapy.Pts who undergo surgery will have pretreatment DCE-MRI, DW-MRI \&/or 1H-MRS studies on the GE 1.5T or 3T MRI scanner. Pts who participate in chemo-radiation therapy protocols will have pretreatment DCE-MRI, DW-MRI \&/or 1H-MRS studies on the 3T Philips MRI scanner in the radiation oncology suite \& will undergo additional recommended weekly DW-MRI including IVIM studies at the same MRI scanner during the course of treatment. Pts will undergo two recommended DCE-MRI studies (unless contraindicated) when possible. 1st intra-treatment DCE-MRI is recommended between the 1st \& 2nd weeks of treatment \& the 2nd intra-treatment DCE-MRI is recommended between the 3rd \& 4th weeks of treatment.

Interventions

DCE-MRI, DW-MRI and MRS

Pts undergo DCE-MRI, DW-MRI or 1\^H-MRS studies on either the 1.5T scanner or the 3T MRI scanners. Patients will be grouped based on their treatment: group one will include pts who undergo surgery (we will no longer accrue pts in this group) \& group two will include pts who undergo chemoradiation therapy.Pts who undergo surgery will have pretreatment DCE-MRI, DW-MRI \&/or 1H-MRS studies on the GE 1.5T or 3T MRI scanner. Pts who participate in chemo-radiation therapy protocols will have pretreatment DCE-MRI, DW-MRI \&/or 1H-MRS studies on the 3T Philips MRI scanner in the radiation oncology suite \& will undergo additional recommended weekly DW-MRI including IVIM studies at the same MRI scanner during the course of treatment. Pts will undergo two recommended DCE-MRI studies (unless contraindicated) when possible. 1st intra-treatment DCE-MRI is recommended between the 1st \& 2nd weeks of treatment \& the 2nd intra-treatment DCE-MRI is recommended between the 3rd \& 4th weeks of treatment.

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patients with histologically proven diagnosis of head and neck cancer or patients with tumors strongly suspicious for head and neck cancer due to clinical features or FNA (fine needle aspiration) cytology assessment.
• Will undergo surgery or chemo-radiation treatment
• Patients must be 18 years or older and have the ability to give informed consent

Exclusion Criteria

• Claustrophobia
• Known reaction to Gd-DTPA
• Pre-operative radiation to primary tumor site
• Contraindication to MRI

1. Pacemaker

2. Aneurysmal clips

3. Metal implants in field of view

4. Pregnant or nursing women

5. Age and mental status wherein he/she is unable to cooperate for MRI study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amita Dave, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Related Links

http://www.mskcc.org

Memorial Sloan-Kettering Cancer Center website

Other Identifiers

NIH R01 CA115895

Identifier Type: -

Identifier Source: secondary_id

06-007

Identifier Type: -

Identifier Source: org_study_id