Validation of 18F-MISO-PET and 18F-FLT-PET

Head and Neck Neoplasms Clinical Trial

Official title:

Validation of 18F-MISO-PET and 18F-FLT-PET by Immunohistochemical Assessment of Head and Neck Cancer Resection Specimen

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00159978
• Other study ID #: 100
• Status: Terminated
• Phase: Phase 1
• First received: September 9, 2005
• Last updated: May 6, 2015
• Start date: July 2005
• Est. completion date: December 2013

Study information

• Verified date: May 2015
• 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

Hypoxia and tumor cell proliferation are important mechanisms contributing to resistance to radiotherapy in human head and neck tumor cells. Currently, assessment of these two tumor characteristics is performed in biopsies using immunohistochemical staining and subsequent analysis. A promising non-invasive method of characterizing a tumor is the use of positron-emission tomography (PET). Specific tracers can be used to detect hypoxia and proliferative activity. 18F-misonidazole is a tracer for hypoxia and 18F-thymidine is a tracer for proliferation.

Patients suffering from head and neck cancer and who will undergo surgery will be included in this study.

One week before the surgery the patients will undergo a CT-scan and a PET-scan with either of the tracers. Shortly before the surgery they will be given immunohistochemically detectable marker substances enabling the characterization of the tumor samples gathered from the resection specimen. These markers are pimonidazole for detection of hypoxia and iododeoxyuridine for detection of tumor cell proliferation.

The data collected by PET-scan will be analysed and compared to the results acquired by immunohistochemistry.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Stage II-IV squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx, planned for curative resection.

• Age >18 years.

• Written informed consent.

Exclusion Criteria:

• Pregnancy.

• Prior treatment for this tumor

• Women breast feeding

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Head and Neck Neoplasms

Intervention

Procedure:
• 18F-FLT and 18F-MISO-PET
18F-FLT-PET-images will be acquired one hour after injection of 250 MBq FLT. 18F-MISO-PET: 400 MBq FMISO will be injected intravenously. Marker administration: The day before surgery (= 24h) pimonidazole (500 mg/m2) will be administered intravenously in 100 ml saline over 20 min. IdUrd (200 mg) will be administered as bolus injection 20 min before surgery.

Locations

Country	Name	City	State
Netherlands	UMC St Radboud, 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	To validate 18F-MISO-PET for detection of tumor hypoxia and 18F-FLT-PET for detection of tumor cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen.		1 month	No
Secondary	To assess if functional information obtained by 18F-MISO-PET and 18F-FLT-PET can improve the definition of target volume for radiotherapy treatment planning.		1 month	No