Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer

NCT ID: NCT01774760

Last Updated: 2019-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-09-30

Brief Summary

The results of previous studies suggest further development of [18F]EF5 as a PET tracer for imaging hypoxia. This is a non-randomized prospective study to obtain information on reproducibility of [18F]EF5 intratumor distribution using repeated pretreatment PET/CT scans.

Detailed Description

All patients will undergo normal diagnostic and staging procedures, including a conventional 18F-FDG PET/CT scan for the purpose of RT or surgical planning. In addition to that, an 18F-EF5 PET/CT scan will be performed on a separate day. The patients receive intravenous injection of 250-350 MBq of [18F]EF5. After that, a venous blood sample will be obtained for measurement of plasma radioactivity. A low-dose CT (helical) will be performed for attenuation correction and anatomical reference. After that, a PET scan will be performed (starting at 3 h after injection). The second 18F-EF5 scan will be performed in a similar way 4-7 days after the first scan. A representative histologic sample of primary tumor is pre-condition for study and an effort is made to store part of fresh histologic material in liquid nitrogen for later use in immunohistochemical analysis.

Patients are scheduled to undergo preoperative or definitive chemoradiotherapy using current clinical standards after completion of the current protocol. Follow-up information (event-free survival and overall survival) will be gathered.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients with stage III-IV head and neck cancer

18F-EF5 PET/CT scan

Group Type: EXPERIMENTAL

18F-EF5

Intervention Type: DRUG

Pretreatment PET/CT-scan (performed two times)

Intervention Type: PROCEDURE

Interventions

18F-EF5

Intervention Type: DRUG

Pretreatment PET/CT-scan (performed two times)

Intervention Type: PROCEDURE

Other Intervention Names

PET/CT static imaging

Eligibility Criteria

Inclusion Criteria

• Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
• Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck
• Primary tumor diameter as determined clinically or from contrast enhanced CT or T1-weighed MRI scan must be at least 15 mm
• Patients with nodal neck metastases of head and neck cancer are eligible
• Mental status: Patients must be able to understand the meaning of the study
• The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
• Patient, if female, must not be pregnant or lactating at the time of the study

Exclusion Criteria

• Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease.
• Patient must have no history of previous chemotherapy or biological therapy or RT for treatment of head and neck cancer.
• Patient must not have an uncontrolled serious infection
• Patients with organ metastases in liver, bone, brain or lung.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Heikki Minn

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heikki Minn, Professor

Role: PRINCIPAL_INVESTIGATOR

Turku University Hospital

Locations

Turku University Hospital

Turku, , Finland

Countries

Finland

Other Identifiers

T14/2013

Identifier Type: -

Identifier Source: org_study_id