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

Phase 1

Terminated

• Conditions: Epithelial Ovarian Cancer
• Interventions: Diagnostic Test: [18F]fluoro-PEG-folate PET/CT scan

• Registration Number: NCT05215496
• Lead Sponsor: Lioe-Fee de Geus-Oei, MD PhD

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2022-01-28
• Study First Posted: 2022-01-31
• Study Start: 2022-05-10
• Primary Completion: 2023-05-01
• Study Completion: 2023-05-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]fluoro-PEG-folate PET/CT scan	[18F]fluoro-PEG-folate PET/CT scan	Patients with FIGO stage IIIB/IIIC epithelial ovarian cancer, 185 MBq of \[18F\]fluoro-PEG-folate.

Primary Outcome Measures

Name	Time	Method
Tolerability of the [18F]fluoro-PEG-folate PET tracer	From administration up to two hours after administration	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.
Pharmacokinetic distribution of the [18F]fluoro-PEG-folate tracer	At regular intervals up to 90 minutes post injection of the tracer.	Blood samples will be collected to determine the pharmacokinetic distribution of the tracer.
Arterial plasma input curve of the [18F]fluoro-PEG-folate tracer	At regular intervals up to 90 minutes post injection of the tracer.	Blood samples will be collected to determine the arterial plasma input curve of the tracer.
Safety of the [18F]fluoro-PEG-folate PET tracer	Up to six weeks after the injection of the tracer.	Total number of AEs and SAEs that occur during the observation period.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and specificity	Up to 6 weeks after the FR-targeted PET/CT scan.	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.

Trial Locations

Locations (1)

Katja Gaarenstroom; 🇳🇱 Leiden, Zuid-holland, Netherlands