The pre-operative assessment of intra-abdominal tumor load in patients with epithelial ovarian cancer (EOC) remains unreliable with standard imaging modalities. The use of tumor targeted imaging, such as folate receptor (FR)-targeted positron emission tomography (PET) imaging could aid in the preoperative assessment of metastatic tumor load. This study aims to evaluate the safety and tolerability, and pharmacokinetics of the \[18F\]fluoro-PEG-folate PET tracer and to assess the sensitivity and specificity of a \[18F\]fluoro-PEG-folate PET/CT scan for the preoperative detection of intra-abdominal metastatic lesions in patients with advanced stage epithelial ovarian cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
5
A dynamic FR-targeted PET scan, a low-dose CT scan without contrast agents, and a static FR-targeted PET scan will be obtained
Katja Gaarenstroom
Leiden, South Holland, Netherlands
Tolerability of the [18F]fluoro-PEG-folate PET tracer
To assess the tolerability of the \[18F\]fluoro-PEG-folate PET tracer vital signs will be recorded every 15 minutes starting directly before administration and continued up to two hours after dosing. The endpoint for this study is the number of patients whose vital signs stayed within a normal range of their baseline.
Time frame: From administration up to two hours after administration
Arterial plasma input curve of the [18F]fluoro-PEG-folate tracer
Blood samples will be collected to determine the arterial plasma input curve of the tracer.
Time frame: At regular intervals up to 90 minutes post injection of the tracer.
Pharmacokinetic distribution of the [18F]fluoro-PEG-folate tracer
Blood samples will be collected to determine the pharmacokinetic distribution of the tracer.
Time frame: At regular intervals up to 90 minutes post injection of the tracer.
Safety of the [18F]fluoro-PEG-folate PET tracer
Total number of AEs and SAEs that occur during the observation period.
Time frame: Up to six weeks after the injection of the tracer.
Sensitivity and specificity
Sensitivity and specificity of the FR-targeted PET/CT scan for the detection of metastatic EOC lesions. Postoperative histopathology will serve as the gold standard.
Time frame: Up to 6 weeks after the FR-targeted PET/CT scan.
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