Functional Imaging in HNC Undergoing Chemoradiation

Head and Neck Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00837980
• Other study ID #: CCR3123
• Status: Recruiting
• Phase: N/A
• First received: February 5, 2009
• Last updated: February 5, 2009
• Start date: February 2009
• Est. completion date: November 2010

Study information

• Verified date: February 2009
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	the ability to define a biological target volume in all the patients
Secondary	to compare the volumes defined by the conventional imaging to the functional imaging
Secondary	to measure changes in the volume of the disease with diff