Magnetic Resonance Imaging (MRI) in the Assessment of Head and Neck Squamous Cell Carcinoma (HNSCC) Response

NCT00994201 | Terminated DMC

• 1 other identifier: OHSU IRB00005554
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to see if new techniques of measuring HNSCC tumors with magnetic resonance imaging (MRI) can help predict how well the tumors will respond to combined chemotherapy and radiation treatment. The investigators hope to find a reliable method to determine whether or not a patient's cancer is responding to chemo-radiation early in their treatment using an MRI, such that that cancer treatments could be tailored to the individual more effective in the future. The MRI techniques include dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), diffusion-weighted magnetic resonance imaging (DW-MRI), and magnetic resonance spectroscopy (MRS). Participants will be subjected to two sessions of MRI scans: one before the initiation of their regular treatment and the second before their second cycle of chemotherapy. Each scanning session will last approximately 45 minutes.

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Determination of early or a prior prognostic markers of head and neck cancers, as measured by DCE-MRI, DW-MRI, and MRS, that characterize the differences between clinical responders and non-responders.

  September 2011

Secondary Outcomes (1)

• Correlation between early/a prior marker and progression-free survival.

  September 2011

Interventions

DCE-MRI, DW-MRI and MRS OTHER

Patients will undergo Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI), Diffusion-weighted magnetic resonance imaging (DW-MRI), Magnetic resonance spectroscopy (MRS) prior to the initiation of chemoradiation and before their second cycle of chemotherapy. Healthy volunteers will undergo DCE-MRI, DW-MRI and MRS.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Potential subjects will be recruited by the Oregon Health and Science University head and neck oncology staff.

You may qualify if:

• Histologically confirmed diagnosis of loco-regionally advanced (stage III or IV) squamous cell carcinoma of the head and neck (oropharynx, hypopharynx and larynx)
• Age \> 18 years
• No prior surgery, chemotherapy or radiation therapy for head and neck cancer
• Scheduled to receive chemoradiation for definitive therapy

You may not qualify if:

• Contraindications to MRI (pacemaker, aneurysm clip, mechanical and/or electrical device or metallic fragment, severe claustrophobia)
• Contraindications to gadolinium
• Severe, active co-morbidity
• Major medical illnesses or psychiatric impairments
• Pregnant or nursing women

Sponsors & Collaborators

• OHSU Knight Cancer Institute: lead
• Medical Research Foundation, Oregon: collaborator
• Radiological Society of North America: collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239-3098, United States

Location

Related Links

• Oregon Health and Science University

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• James A. Tanyi, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: October 13, 2009
• First Posted: October 14, 2009
• Study Start: October 1, 2011
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: March 25, 2016

Record last verified: 2016-03

Locations

US (1)