Functional Imaging in HNC Undergoing Chemoradiation | NCT00837980

Studies
Functional Imaging in HNC Undergoing Chemoradiation

NCT00837980

Sponsor

Royal Marsden NHS Foundation Trust

Status

Unknown status

Last Update Posted

Feb 6, 2009Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Head and Neck Cancer

Interventions

Not provided

Countries

United Kingdom

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

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Nov 2010Estimated

Completion Date

Nov 2010Estimated

First Submitted Date

Feb 5, 2009

First Submission Date that Met QC Criteria

Feb 5, 2009

First Posted Date

Feb 6, 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

Feb 5, 2009

Last Update Posted Date

Feb 6, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 the study is to generate a library of functional imaging and anatomical imaging for patients with head and neck cancers for evaluation of new radiotherapy strategies and planning techniques including IMRT. Secondary aims would be to observe the changes in the cancers as the treatment progresses as well as to define the biologically most active part of the tumor (biological target volume) which could be given more intensive treatment. Tumor volumes seen on different imaging modalities will be compared with a hope of finding an optimal imaging methodology for accurate visualization of the head and neck cancers

Detailed Description

Adult patients who have a head and neck cancer and are planned to receive chemotherapy and radiotherapy will be invited to participate in the study. Patients who are not in very good health, have diabetes or kidney failure will not be considered for the study. Also patients who can not undergo MRI scan or are allergic to contrast injection given prior to the scan or have had any other form of cancer (except skin cancer) will also be excluded from the study.

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

10Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the number of patients completing the study protocol and adding to the library of images to be used for evaluation of new radiotherapy strategies and planning techniques including IMRT

Secondary Outcomes

Measure	Description	Time Frame
the ability to define a biological target volume in all the patients
to compare the volumes defined by the conventional imaging to the functional imaging

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with histologically proven head and neck cancer, planed for chemotherapy and radiotherapy
age more than 18 years
patient willing to participate and has signed a consent form
patients in good physical status (WHO performance status 0-2)

Exclusion Criteria:

patients in poor health (WHO performance status >2)
patients with any other cancer apart from skin cancer
patients with contraindications to MRI scan and IV contrast
diabetic patients
patients with renal failure

Accepts Healthy Volunteers

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Royal Marsden NHS Foundation Trust	Recruiting	Sutton	Surrey	SM6 9QD	United Kingdom

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms