Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors

Head and Neck Neoplasms Clinical Trial

Official title:

Value of FLT-PET Before and During Radiotherapy in Head and Neck Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00163176
• Other study ID #: 049
• Status: Completed
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: December 15, 2011
• Start date: July 2005
• Est. completion date: December 2010

Study information

• Verified date: December 2011
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

Tumor cell proliferation and repopulation contribute to resistance to radiotherapy in head and neck cancer. Up to now, this characteristic is mostly assessed using biopsies acquired during inspection under general anaesthesia before treatment.

18F-FLT-PET (positron emission tomography) is a non-invasive imaging method showing areas of active proliferation. The aim of this study is to assess the value of the functional information gained by 18F-FLT-PET for radiotherapy planning and early tumor response assessment.

Prior to radiotherapy, a planning CT-scan and a 18F-FLT-PET scan are acquired. After approximately two weeks of radiotherapy a further PET scan is obtained.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2010
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Stage II - IV squamous cell carcinoma of the head-and-neck region, treated with radiotherapy or radiochemotherapy with curative intent.

2. 18 years or older

3. Informed consent

Exclusion Criteria:

1. Patients who have undergone surgery as primary tumor therapy.

2. Patients treated with palliative intent.

3. Pregnancy

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen, Department of Radiotherapy	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of 18F-FLT-PET-signal changes before and during therapy with treatment outcome (clinical response and local tumor control)		1 year	No
Secondary	Evaluation of the value of the functional information gained by 18F-FLT-PET regarding the definition of the planning target volume (PTV) for radiotherapy.		2 months	No
Secondary	Measurement of 18F-FLT-PET-signal changes during radiotherapy or radiochemotherapy.		2 months	No