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

This study is currently recruiting participants.
Verified March 2013 by Turku University Hospital
Sponsor:
Information provided by (Responsible Party):
Heikki Minn, Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01774760
First received: January 21, 2013
Last updated: March 26, 2013
Last verified: March 2013
History of Changes
  Purpose

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

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • 18F-EF5 standardized uptake values (SUV) [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
    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:
  • Event-free and overall survival [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]
  • Association of uptake of [18F]EF5 with molecular markers known to be associated in hypoxia and malignant progression [ Time Frame: 2-3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 18F-EF5 PET/CT scan Drug: 18F-EF5 Procedure: Pretreatment PET/CT-scan (performed two times)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01774760

Contacts
Contact: Heikki Minn, Professor + 358 2 3130149 heminn@utu.fi
Contact: Antti Silvoniemi, M.D. +358 2 3130000 anmisi@utu.fi

Locations
Finland
Turku University Hospital Recruiting
Turku, Finland, FI-20521
Contact: Antti Silvoniemi, M.D.     +358-2-3130000     anmisi@utu.fi    
Sponsors and Collaborators
Turku University Hospital
Investigators
Principal Investigator: Heikki Minn, Professor Turku University Hospital
  More Information

No publications provided

Responsible Party: Heikki Minn, Professor, Turku University Hospital
ClinicalTrials.gov Identifier: NCT01774760     History of Changes
Other Study ID Numbers: T14/2013
Study First Received: January 21, 2013
Last Updated: March 26, 2013
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by Turku University Hospital:
18F-EF5
PET/CT
Reproducibility

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

ClinicalTrials.gov processed this record on May 21, 2013