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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01774760
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : October 21, 2016
Information provided by (Responsible Party):
Heikki Minn, Turku University Hospital

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.

Condition or disease Intervention/treatment Phase
Squamous Cell Carcinoma of the Head and Neck Drug: 18F-EF5 Procedure: Pretreatment PET/CT-scan (performed two times) Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
Study Start Date : March 2013
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 18F-EF5 PET/CT scan Drug: 18F-EF5 Procedure: Pretreatment PET/CT-scan (performed two times)

Primary Outcome Measures :
  1. 18F-EF5 standardized uptake values (SUV) [ Time Frame: 2-3 years ]
    Volume of interests (VOIs) are determined in the acquisition images of the [18F]EF5 studies. The spatial overlap of the VOIs of the two [18F]EF5 studies will be evaluated.

Secondary Outcome Measures :
  1. Event-free and overall survival [ Time Frame: 2-3 years ]
  2. Association of uptake of [18F]EF5 with molecular markers known to be associated in hypoxia and malignant progression [ Time Frame: 2-3 years ]

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01774760

Turku University Hospital
Turku, Finland, FI-20521
Sponsors and Collaborators
Turku University Hospital
Principal Investigator: Heikki Minn, Professor Turku University Hospital

Responsible Party: Heikki Minn, Professor, Turku University Hospital Identifier: NCT01774760     History of Changes
Other Study ID Numbers: T14/2013
First Posted: January 24, 2013    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016

Keywords provided by Heikki Minn, Turku University Hospital:

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Neoplasms by Site