Squamous Cell Carcinoma of the Head and Neck
Conditions
Keywords
18F-EF5, PET/CT, Reproducibility
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.
Interventions
DRUG18F-EF5
PROCEDUREPretreatment PET/CT-scan (performed two times)
Sponsors
Turku University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Finland
Participant flow
Recruitment details
11 were recruited, 10 started and completed
Pre-assignment details
1 patient withdrawn because of a negative FDG PET scan
Participants by arm
| Arm | Count |
|---|---|
| 18F-EF5 PET/CT Scan 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 | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | 18F-EF5 PET/CT Scan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Region of Enrollment Finland | 10 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
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
Time frame: Baseline and 7 days (ie time between the two scans)
Population: Head and neck squamous cell carcinoma
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients With Stage III-IV Head and Neck Cancer | Change From Baseline in 18F-EF5 Standardized Uptake Values (SUV) | 1.49 SUVmax | Standard Deviation 0.16 |