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

February 5, 2009
February 5, 2009
February 2009
November 2010   (final data collection date for primary outcome measure)
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
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Functional Imaging in HNC Undergoing Chemoradiation
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)

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

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

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.

Head and Neck Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
November 2010
November 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United Kingdom
 
NCT00837980
CCR3123
No
Dr Kate Newbold/ Chief Investigator, Royal Marsden Hospital NHS Foundation Trust
Royal Marsden NHS Foundation Trust
Not Provided
Not Provided
Royal Marsden NHS Foundation Trust
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP