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

• Sponsor: Turku University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01774760
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 42.1
• Patients Per Site Per Month: 0.2

Study Details

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.

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

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Reproducibility of Intratumor Distribution of 18F-EF5 in Head and Neck Cancer
• Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Sep 1, 2016
• Actual Study Completion Date: Sep 1, 2016

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Turku University Hospital	Turku		Finland	FI-20521

Sponsors and Collaborators

• Turku University Hospital

Investigators

• Principal Investigator: Heikki Minn, Professor, Turku University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Heikki Minn, Professor, Turku University Hospital
• ClinicalTrials.gov Identifier: NCT01774760
• Other Study ID Numbers: T14/2013
• First Posted: Jan 24, 2013
• Last Update Posted: Oct 4, 2019
• Last Verified: Sep 1, 2019

• Keywords provided by Heikki Minn, Professor, Turku University Hospital: 18F-EF5; PET/CT; Reproducibility
• Additional relevant MeSH terms: Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Study Results

Participant Flow

Recruitment Details	11 were recruited, 10 started and completed
Pre-assignment Detail	1 patient withdrawn because of a negative FDG PET scan

Arm/Group Title	18F-EF5 PET/CT Scan
Arm/Group Description	18F-EF5 Pretreatment PET/CT-scan (performed two times)
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	18F-EF5 PET/CT Scan
Arm/Group Description	10 pts with HNSCC. See Table 1 (p. 163) in Eur J Nucl Med Mol Imaging 2018;45:161-169 https://doi.org/10.1007/s00259-017-3857-3
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	3 30%
>=65 years	7 70%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	10 100%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	10 100%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
Finland	10 100%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV)
Description	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
Time Frame	Baseline and 7 days (ie time between the two scans)

Outcome Measure Data

Analysis Population Description

Head and neck squamous cell carcinoma

Arm/Group Title	Patients With Stage III-IV Head and Neck Cancer
Arm/Group Description	Patients undergoing radiation treatment planning who receive pretreatment PET/CT-scan twice within 1 week as an experimental procedure
Measure Participants	10
Mean (Standard Deviation) [SUVmax]	1.49 (0.16)

Adverse Events

Arm/Group Title	18F-EF5 PET/CT Scan
Arm/Group Description	18F-EF5 Pretreatment PET/CT-scan (performed two times)
All Cause Mortality
	18F-EF5 PET/CT Scan
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	18F-EF5 PET/CT Scan
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	18F-EF5 PET/CT Scan
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.