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

September 13, 2019 updated by: Heikki Minn, Turku University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, FI-20521
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with stage III-IV head and neck cancer
18F-EF5 PET/CT scan
Drug: 18F-EF5
Other Names:
  • PET/CT static imaging
Procedure: Pretreatment PET/CT-scan (performed two times)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)
Time Frame: Baseline and 7 days (ie time between the two scans)
Standardized Uptake Values (SUV) are determined in the acquisition images of the [18F]EF5 studies.The difference between the baseline and second SUV is calculated and Bland-Altman plots are generated to compare the group means
Baseline and 7 days (ie time between the two scans)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

January 21, 2013

First Submitted That Met QC Criteria

January 21, 2013

First Posted (ESTIMATE)

January 24, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 4, 2019

Last Update Submitted That Met QC Criteria

September 13, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T14/2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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