E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Epithelial ovarian cancer (EOC) |
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E.1.1.1 | Medical condition in easily understood language |
Epithelial ovarian cancer (EOC) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To evaluate the safety and tolerability of the [18F]fluoro-PEG-folate PET tracer 2. To determine the pharmacokinetics (metabolic stability, biodistribution, clearance rate) of the [18F]fluoro-PEG-folate PET tracer
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E.2.2 | Secondary objectives of the trial |
To examine the sensitivity of [18F]fluoro-PEG-folate PET/CT imaging for the detection of metastatic lesions in patients with advanced stage EOC |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 [2,22] 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 [2,22] was found before NACT c) and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT
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E.4 | Principal 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. Impaired renal function (defined as eGFR < 50 mL/1.73 m2) 5. Impaired liver function (ALT, AST or total bilirubin > 3x upper limit of normal) 6. Clinically significant abnormalities on ECG and/or clinically laboratory test 7. Inability to tolerate lying supine for the duration of a PET/CT examination (~110 minutes) 8. 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 9. Patients not able to comply with the study procedures 10. Patients who did not give informed consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
Tolerability assessments: (blood pressure (mmHg), pulse rate (bpm), peripheral oxygen saturation, respiratory rate, temperature and ECG (PR, QRS, QT), (serious) adverse events and the concomitant use of other medications throughout the study period. Pharmacokinetic parameters: the volume of distribution (VT) and several semiquantitative parameters (standardized uptake values). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to two weeks after the administration of the [18F]fluoro-PEG-folate tracer. |
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E.5.2 | Secondary end point(s) |
Preoperative PET-positive lesions and routine conventional CT findings will be compared on the basis of the peritoneal cancer index (PCI) and a per-lesion based analysis. Postoperative histological findings will be regarded as the gold standard for presence, magnitude and localization of metastatic lesions. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The early stopping rule will be used if after 5 patients, ≥ 3 patients show negative PET signal, while folate receptor (FR) expression is present in immunohistochemical analysis. If so, the study will be terminated. If not, the study will continue including the remaining patients. This rule will also be initiated if all of the first 3 patients show negative PET signal, while showing expression of FR by immunohistochemistry on resected tissues. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |