Functional Imaging in HNC Undergoing Chemoradiation

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2009 by Royal Marsden NHS Foundation Trust.
Recruitment status was Recruiting

Sponsor:

Information provided by:

Royal Marsden NHS Foundation Trust

ClinicalTrials.gov Identifier:

NCT00837980

First received: February 5, 2009

Last updated: NA

Last verified: February 2009

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 5, 2009
Last Updated Date	February 5, 2009
Start Date ^ICMJE	February 2009
Estimated Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 5, 2009)	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
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: February 5, 2009)	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 to measure changes in the volume of the disease with diff
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Functional Imaging in HNC Undergoing Chemoradiation
Official Title ^ICMJE	Investigation of the Role of Functional Imaging in Characterising Radiotherapy Target Volumes and Assessing Disease Response in Patients Undergoing Chemoradiation for Head and Neck Cancer (HNC)
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.
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	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.
Condition ^ICMJE	Head and Neck Cancer
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	10
Estimated Completion Date	November 2010
Estimated Primary Completion Date	November 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United Kingdom

Administrative Information
NCT Number ^ICMJE	NCT00837980
Other Study ID Numbers ^ICMJE	CCR3123
Has Data Monitoring Committee	No
Responsible Party	Dr Kate Newbold/ Chief Investigator, Royal Marsden Hospital NHS Foundation Trust
Study Sponsor ^ICMJE	Royal Marsden NHS Foundation Trust
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Royal Marsden NHS Foundation Trust
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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