Epithelial ovarian cancer
Conditions
Interventions
• A screening visit including ECG prior to the performance of the
[18F]fluoro-PEG-folate PET/CT scan
• Intravenous administration of [18F]fluoro-PEG-folate prior to the
[18F]fluoro-PEG-folate PET/CT
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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 a) in whom EOC is histologically proven, or b) 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 a) in whom EOC is histologically proven, or b) in whom EOC is cytologically suspected and a serum CA125/CEA ratio > 25 was found before NACT c) and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT
Exclusion criteria
Exclusion criteria: 1. Women younger than 30 years of age (in accordance with the guidelines of the Netherlands Commission on Radiation Dosimetry, as the total radiation dose will be 7.2 mSv) 2. Patients who previously underwent primary laparotomy and in whom complete or optimal cytoreduction was not considered feasible. 3. Contraindication for PET (pregnancy, lactating or severe claustrophobia) 4. Thrombocytopenia (platelet count 2 5. Impaired renal function (defined as eGFR 3x upper limit of normal) 7. Clinically significant abnormalities on ECG and/or clinically laboratory test 8. Inability to tolerate lying supine for the duration of a PET/CT examination (~110 minutes) 9. 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 10. Patients not able to comply with the study procedures 11. Patients who did not give informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study will be to evaluate the safety, tolerability and pharmacokinetics of the [18F]fluoro-PEG-folate tracer. Tolerability assessments (blood pressure (mmHg), pulse rate (bpm), peripheral oxygen saturation, respiratory rate, temperature will be recorded at regular intervals (every 15 minutes) starting directly before administration and continued up to two hours after dosing. Following the [18F]fluoro-PEG-folate PET/CT scan, an ECG (PR, QRS, QT) will be performed. Additionally, (serious) adverse events and the concomitant use of other medications throughout the study period (defined as up to six weeks after the administration of the [18F]fluoro-PEG-folate tracer) will be recorded. Furthermore, pharmacokinetics will be determined. Manual blood samples will be used to determine the arterial input curve and to calibrate and correct it for plasma-to-whole blood concentration ratios and labelled protein binding fractions, thereby generating a protein binding corrected, arterial plasma input function. Full-kinetic quantitative analysis will be performed using 1-tissue and both irreversible and reversible 2-tissue compartment models, all with an additional blood volume fraction parameter consisting of whole-blood activity. Pharmacokinetic parameters will be extracted, such as the volume of distribution (VT). Furthermore, several simplified uptake metrics will be derived, such as several semiquantitative parameters (standardized uptake values). In this way, we are able to determine which model best describes the kinetics of the radiotracer and which simplified and/or semiquantitative parameter correlates best for accurate quantification of [18F]fluoro-PEG-folate uptake in whole-body PET/CT scans. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of the study is to investigate the sensitivity and specificity of the [18F]fluoro-PEG-folate PET/CT scan for the detection of metastatic disease in epithelial ovarian cancer. This will independently be determined qualitatively as well as quantitatively by two nuclear medicine physicians, using the Peritoneal Cancer Index (PCIPET/CT). This PCI indicates the presence of large (> 5 cm), moderate (0.5-5 cm), small ( | — |
Countries
Netherlands
Outcome results
None listed