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

Primary Purpose

Squamous Cell Carcinoma of the Head and Neck

Status

Completed

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

18F-EF5

Pretreatment PET/CT-scan (performed two times)

About this trial

This is an interventional diagnostic trial for Squamous Cell Carcinoma of the Head and Neck focused on measuring 18F-EF5, PET/CT, Reproducibility

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Turku University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with stage III-IV head and neck cancer

Arm Description

18F-EF5 PET/CT scan

Outcomes

Primary Outcome Measures

Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)

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

Secondary Outcome Measures

Full Information

NCT ID

NCT01774760

First Posted

January 21, 2013

Last Updated

September 13, 2019

Sponsor

Turku University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01774760

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

March 2013 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Turku University Hospital

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma of the Head and Neck

Keywords

18F-EF5, PET/CT, Reproducibility

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with stage III-IV head and neck cancer

Arm Type

Experimental

Arm Description

18F-EF5 PET/CT scan

Intervention Type

Drug

Intervention Name(s)

18F-EF5

Other Intervention Name(s)

PET/CT static imaging

Intervention Type

Procedure

Intervention Name(s)

Pretreatment PET/CT-scan (performed two times)

Primary Outcome Measure Information:

Title

Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)

Description

Time Frame

Baseline and 7 days (ie time between the two scans)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Heikki Minn, Professor

Organizational Affiliation

Turku University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Turku University Hospital

City

Turku

ZIP/Postal Code

FI-20521

Country

Finland

12. IPD Sharing Statement

Learn more about this trial

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

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