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

Phase 2
18 Years
80 Years
Open (Enrolling)
Squamous Cell Carcinoma of the Head and Neck

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Trial Information

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

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.

Inclusion Criteria:

- Performance status: Karnofsky score 70 or better or WHO performance status 2 or

- 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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

18F-EF5 standardized uptake values (SUV)

Outcome Description:

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.

Outcome Time Frame:

2-3 years

Safety Issue:


Principal Investigator

Heikki Minn, Professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Turku University Hospital


Finland: Finnish Medicines Agency

Study ID:




Start Date:

March 2013

Completion Date:

January 2015

Related Keywords:

  • Squamous Cell Carcinoma of the Head and Neck
  • 18F-EF5
  • PET/CT
  • Reproducibility
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms