Magnetic Resonance Imaging (MRI) in the Assessment of Hea... | NCT00994201

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

NCT00994201

Sponsor

OHSU Knight Cancer Institute

Status

Terminated

Last Update Posted

Mar 25, 2016Estimated

Enrollment

10Actual

Phase

Not provided

Conditions

Head and Neck Cancer

Interventions

DCE-MRI, DW-MRI and MRS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study never accrued sufficient subjects

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Oct 13, 2009

First Submission Date that Met QC Criteria

Oct 13, 2009

First Posted Date

Oct 14, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2016

Last Update Posted Date

Mar 25, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

James Tanyi, Clinical Associate Professor, OHSU Knight Cancer InstitutePrincipal Investigator

Lead Sponsor

OHSU Knight Cancer InstituteOTHER

Collaborators

Name	Class
Medical Research Foundation, Oregon	OTHER
Radiological Society of North America	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

DCE-MRI, DW-MRI, MRS have the potential to measure early cellular changes that occur in response to successful therapies, such as chemoradiation, and have been demonstrated to be early predictors not only of therapeutic response, but also of overall survival for other malignancies. Our long-term goal is to use these imaging techniques to develop non-invasive functional imaging methodologies that would be better predictors of pathological response than the current clinical standard.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Correlation between early/a prior marker and progression-free survival.		September 2011

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James A. Tanyi, PhD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Oregon Health and Science University		Portland	Oregon	97239-3098	United States

Label	URL
Oregon Health and Science University	View source

Condition Browse Module

MeSH Terms

ID	Term
D006258	Head and Neck Neoplasms

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided