Clinical trial NCT00837980: Functional Imaging in HNC Undergoing Chemoradiation
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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Head and Neck Cancer
Keywords: head and neck cancer
DW MRI
PET
DCE MRI
functional imaging
IMRT
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
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
Secondary outcomes:
measure: the ability to define a biological target volume in all the patients
measure: to compare the volumes defined by the conventional imaging to the functional imaging
measure: to measure changes in the volume of the disease with diff
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
References: