Primary objective:To investigate the feasibility of a novel high-resolution 18F-FDG PET-CT of surgical specimens of OSCC, STS and OS and compare the results to the gold standard of histopathology. Secondary Objectives:To assess the diagnostic…
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Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study is to determine the feasibility of 18F-FDG PET-CT
specimen imaging for intraoperative margin assessment in OSCC, STS and OS
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 outcome
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.
Background summary
The ideal outcome in oncological surgery is resection of all tumor tissue with
a margin of healthy
tissue. However, positive surgical margins (PSMs) occur in up to 35% of the
cases, depending on
tumor type. The final margin status is only available five to seven days after
surgery so that in
case of a PSM, intensive adjuvant radiotherapy or chemotherapy is necessary.
Despite adjuvant
treatment, patients still have a significantly reduced overall
survival.*Therefore, the intraoperative
identification of PSMs is paramount to enable surgical corrections and obtain a
complete
resection.
Study objective
Primary objective:
To investigate the feasibility of a novel high-resolution 18F-FDG PET-CT of
surgical specimens of OSCC, STS and OS and compare the results to the gold
standard of histopathology.
Secondary Objectives:
To assess the diagnostic accuracy of the high-resolution mobile PET-CT, the
PET-CT margin status results are compared to the results of the gold standard
of histopathology. This will be quantified as diagnostic sensitivity,
specificity, negative predictive value and positive predictive value.
To investigate the ability of high-resolution 18F-FDG PET-CT for intraoperative
assessment of lymph node status, in case lymph node excision is performed
during OSCC, STS and OS surgery. This will be quantified as diagnostic
sensitivity and specificity compared to the gold standard of histopathological
examination;
To compare the high-resolution 18F-FDG PET-CT specimen images with preoperative
whole-body 18F-FDG PET-CT images of the same patients, if available. This
comparison will provide insight into tissue uptake that is detected at
different levels of spatial resolution;
To investigate possible relations between 18F-FDG tumor uptake and
histopathological characteristics of the tumor;
Study design
The study is designed as follows:
Patients eligible for inclusion have biopsy-confirmed OSCC, STS or OS and are
scheduled for surgical treatment.
Patients interested will be informed about the study at the outpatient clinic
and in-/exclusion criteria will be checked. Patients have a maximum of one week
to decide whether they participate in the study or not. This one-week interval
will never delay the surgical intervention. Written informed consent will be
obtained.
On the day of surgery, 2.0 MBq/kg 18F-FDG will be adminstered at the Department
of Nuclear Medicine and Molecular Imaging.
Surgery is performed according to standard of care. The perioperative
personnel, as deemed necessary based on risk analysis by clinical
physicist/radiation safety expert, will wear electronic dosimeters. Pregnant
personnel is not allowed in the operation room as long as the patient is
present. Directly after surgery, high-resolution PET-CT imaging of the surgical
specimen is performed. No treatment decisions will be taken based on the images
acquired by the specimen imager. Additional resected tissue (e.g. lymph nodes)
could also be imaged by the high-resolution PET-CT specimen imager.
All resected specimens are sent to the Department of Pathology for
standard-of-care histopathological analysis.
Intervention
Administration of 18F-FDG (0.8 MBq/kg)
Study burden and risks
Administration of the radiotracer takes place during standard care admission of
the patient
The whole-body radioactive dose of the administered tracer is estimated at 1.2
mSv. In comparison, a chest X-ray has a dose of 0.4 mSv, a chest CT scan
results in a dose of 6.1 mSv and a person living at sea level for a year is
exposed to about 2.4 mSv of natural radiation. Therefore, the risk associated
with the exposed radiation caused by the administered low-dose tracer is
estimated to be low.
For hospital personnel involved in study procedure: The perioperative
personnel, as deemed necessary based on risk analysis by clinical
physicist/radiation safety expert, will wear electronic dosimeters. Pregnant
personnel is not allowed in the operation room as long as the patient is
present.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
Age >=18 years.
Patient is confirmed with oral squamous cell carcinoma, soft tissue sarcoma or
osteosarcoma.
Patient is indicated to undergo curative surgery of the primary tumor.
Patient diagnosed with STS have received neoadjuvant radiotherapy of the
primary tumor.
Patient is estimated compliant for study participation by the investigator.
Written informed consent.
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;
A blood glucose level over 200 mg/dL on the day of surgery.
Patients diagnosed with OSCC and OS having received neoadjuvant radiotherapy of
the primary tumor region;
Pregnancy or lactation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL86142.042.24 |