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
  Purpose

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


Condition
Head and Neck Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Royal Marsden NHS Foundation Trust:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

Estimated Enrollment: 10
Study Start Date: February 2009
Estimated Study Completion Date: November 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837980

Locations
United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM6 9QD
Contact: Kate Newbold    02086613638    kate.newbold@rmh.nhs.uk   
Contact: Prased Dandekar    02086613453    prased.dankekar@rmh.nhs.uk   
Principal Investigator: Kate Newbold         
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
  More Information

No publications provided

Responsible Party: Dr Kate Newbold/ Chief Investigator, Royal Marsden Hospital NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00837980     History of Changes
Other Study ID Numbers: CCR3123
Study First Received: February 5, 2009
Last Updated: February 5, 2009
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Royal Marsden NHS Foundation Trust:
head and neck cancer
DW MRI
PET
DCE MRI
functional imaging
IMRT

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms

ClinicalTrials.gov processed this record on September 14, 2014