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.|
|ClinicalTrials.gov Identifier: NCT01774760|
Recruitment Status : Completed
First Posted : January 24, 2013
Last Update Posted : October 21, 2016
|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|
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)|
|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|
|Experimental: 18F-EF5 PET/CT scan||
Procedure: Pretreatment PET/CT-scan (performed two times)
- 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.
- Event-free and overall survival [ Time Frame: 2-3 years ]
- Association of uptake of [18F]EF5 with molecular markers known to be associated in hypoxia and malignant progression [ Time Frame: 2-3 years ]
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 ClinicalTrials.gov identifier (NCT number): NCT01774760
|Turku University Hospital|
|Turku, Finland, FI-20521|
|Principal Investigator:||Heikki Minn, Professor||Turku University Hospital|