head and neck cancer, colorectal cancer, urogenital carcinoma, soft tissue sarcoma or osteosarcoma head and neck cancer, colorectal cancer, urogenital carcinoma, soft tissue sarcoma or osteosarcoma
Conditions
Interventions
Mobile high-resolution PET-CT specimen imager.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >=18 years. Patient has biopsy-confirmed head and neck cancer, colorectal cancer, urogenital carcinoma, soft tissue sarcoma or osteosarcoma.Tumor-type is known to be 18F-FDG PET-avid Patient is indicated to undergo curative surgery of the primary tumor. Patient is estimated compliant for study participation by the investigator. Written informed consent.
Exclusion criteria
Exclusion criteria: Medical or psychiatric conditions that compromise the patient’s ability to give informed consent; Patient has participated in other clinical studies with radiation exposure of more than 1 mSv in the past 12 months; Tumor is larger than 10 centimetres in diameter and 6.5 centimetres in heightA blood glucose level over 200 mg/dL on the day of surgery. Pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to determine the feasibility of 18F-FDG PET-CT specimen imaging for intraoperative margin assessment in head and neck cancer, colorectal cancer, urogenital carcinoma, soft tissue sarcoma or osteosarcoma surgery. The feasibility is assessed by examining whether the amount of signal is sufficiënt for the PET-CT to produce a representative 3D reconstruction that allows margins to be measured at the millimeter level, corresponding to standard of care histopathological evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| The clinical value is measured as diagnostic performance, for which the following parameters will be will be calculated: sensitivity (the proportion of positive final margins that are correctly identified as final positive); specificity (the proportion of negative final margins that are correctly identified as final negative); positive predictive value (the proportion of positive final margins that are true positive); negative predictive value (the proportion of negative final margins that are true negative); The results of histopathological analysis are considered as the golden standard and thus represent the *correct* margin status. Failure rate and interobserver reproducibility will also be reported by a descriptive analysis. The standardized uptake values (SUVpeak, SUVmax) of each lymph node scanned will be correlated with metastatic status. The SUVs of benign and malignant lymph nodes will be described as as measurements of distribution: (geometric) means with standard deviation; medians with range; frequencies. To get an idea of the discriminative potential of PET-CT, a cut-off SUV value will be determined based on Youden's index. For tumors where preoperative whole-body 18F-FDG PET-CT is available, the correlation between whole-body 18F-FDG uptake and specimen-imaging 18F-FDG uptake is studied. A Pearson correlation coefficient will be calculated. Patient demographics (e.g. age, sex) and pathological characteristics (e.g. diagnostic status or histopathological subtype) will be presented using descriptive statistics. These will include measurements of distribution: (geometric) means with standard deviation; medians with range; frequencies. Continuous variables will be considered non-normally distributed due to the low sample size. | — |
Countries
Netherlands
Contacts
Public ContactJasper Vonk
Universitair Medisch Centrum Groningen
Outcome results
None listed