Functional Imaging in HNC Undergoing Chemoradiation

NCT00837980 | Unknown

• 1 other identifier: CCR3123
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; DW MRI; PET; DCE MRI; functional imaging; IMRT

Outcome Measures

Primary Outcomes (1)

• 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 (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM6 9QD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 5, 2009
• First Posted: February 6, 2009
• Study Start: February 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 6, 2009

Record last verified: 2009-02

Locations

GB (1)