Clinical trial · Interventional
[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Reached the stop criteria after the interim analysis
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]fluoro-PEG-folate PET/CT scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]fluoro-PEG-folate PET/CT scan
- description
- Patients with FIGO stage IIIB/IIIC epithelial ovarian cancer, 185 MBq of \[18F\]fluoro-PEG-folate.
- interventionNames
- Diagnostic Test: [18F]fluoro-PEG-folate PET/CT scan
Primary outcomes (4)
- measure
- Tolerability of the [18F]fluoro-PEG-folate PET tracer
- timeFrame
- From administration up to two hours after administration
- description
- 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.
- measure
- Arterial plasma input curve of the [18F]fluoro-PEG-folate tracer
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
Show eligibility criteria text
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 1. in whom EOC is histologically proven, or 2. 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 1. in whom EOC is histologically proven, or 2. in whom EOC is cytologically suspected and a serum CA125/CEA ratio \> 25 was found before NACT 3. and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT Exclusion Criteria: 1. 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) 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 \< 100 x 10\^9/L) and/or INR \> 2 5. Impaired renal function (defined as eGFR \< 50 mL/1.73 m2) 6. Impaired liver function (ALT, AST or total bilirubin \> 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
References
Publications (1)
- DERIVEDCiggaar IA, de Muynck LDAN, de Geus-Oei LF, van Velden FHP, de Kroon CD, Pereira Arias-Bouda LM, Noortman WA, van Persijn van Meerten EL, Dibbets-Schneider P, Helmerhorst HJF, Windhorst AD, Vahrmeijer AL, Peters ITA, Gaarenstroom KN. Preoperative [18F]fluoro-PEG-folate PET/CT in advanced stage epithelial ovarian cancer: A safety and feasibility study. Nucl Med Biol. 2024 Nov-Dec;138-139:108952. doi: 10.1016/j.nucmedbio.2024.108952. Epub 2024 Sep 19. PMID 39326323