[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer

Study Overview
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Brief Summary
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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.

Official Title
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[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer

Conditions
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Epithelial Ovarian Cancer

Intervention / Treatment
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* Diagnostic Test: [18F]fluoro-PEG-folate PET/CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with radiologically FIGO stage IIIB/IIIC EOC based on the conventional CT scan who are: scheduled to undergo primary cytoreductive surgery and in whom EOC is histologically proven, or in whom EOC is cytologically suspected and a serum CA125/CEA ratio > 25 is found or treated with neoadjuvant chemotherapy (NACT) and are scheduled to undergo interval cytoreductive surgery and in whom EOC is histologically proven, or in whom EOC is cytologically suspected and a serum CA125/CEA ratio > 25 was found before NACT and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT Exclusion Criteria: Women younger than 30 years of age (in accordance with the guidelines of the Netherlands Commission on Radiation Dosimetry [23], as the total radiation dose will be 7.2 mSv) Patients who previously underwent primary laparotomy and in whom complete or optimal cytoreduction was not considered feasible. Contraindication for PET (pregnancy, lactating or severe claustrophobia) Thrombocytopenia (platelet count < 100 x 10^9/L) and/or INR > 2 Impaired renal function (defined as eGFR < 50 mL/1.73 m2) Impaired liver function (ALT, AST or total bilirubin > 3x upper limit of normal) Clinically significant abnormalities on ECG and/or clinically laboratory test Inability to tolerate lying supine for the duration of a PET/CT examination ( 110 minutes) Patients with concomitant malignancy (except basal cell carcinoma of the skin) or any condition that in the opinion of the investigators could potentially jeopardize the health status of the patient Patients not able to comply with the study procedures Patients who did not give informed consent

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: 185 MBq of [18F]fluoro-PEG-folate PET tracer will be intravenously administered to 15 patients with radiologically advanced stage EOC who are scheduled to undergo cytoreductive surgery, after which an FR-targeted PET/CT will be made. FR-targeted PET/Ct results will be compared to the intraoperative findings, postoperative histopathology (gold standard) and the conventional CT scan.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]fluoro-PEG-folate PET/CT scan<br>Patients with FIGO stage IIIB/IIIC epithelial ovarian cancer, 185 MBq of [18F]fluoro-PEG-folate. | Diagnostic Test: [18F]fluoro-PEG-folate PET/CT scan<br>* A dynamic FR-targeted PET scan, a low-dose CT scan without contrast agents, and a static FR-targeted PET scan will be obtained<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Up to six weeks after the injection of the tracer. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Up to 6 weeks after the FR-targeted PET/CT scan. |