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NCT00406289 Clinical Trial

Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) in Patients With Head and Neck Tumor

Head and Neck Tumor Clinical Trial

Official title:
Phase I Trial of Adaptive 18F-FDG-PET Biological Intensity-modulated Radiotherapy (BG-IMRT) With Patients With Head and Neck Tumor

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00406289
Other study ID # 2006/391
Secondary ID
Status Completed
Phase Phase 1
First received November 30, 2006
Last updated September 3, 2010
Start date November 2006
Est. completion date February 2010

Study information
Verified date September 2010
Source University Hospital, Ghent
Contact n/a
Is FDA regulated No
Health authority Belgium: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This study will evaluate the feasibility of higher and prolonged dose escalation concentrated in the intra-tumoral regions which are FDG-avid after two weeks of radiotherapy.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date February 2010
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Head and neck tumor

- Aged > 18 years

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• 18F-FDG-PET radiotherapy

Locations
Country Name City State
Belgium University Hospital Ghent Ghent

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Ghent

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor recurrences
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External Links