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

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.

Study Overview

• Status: Terminated
• Conditions: Epithelial Ovarian Cancer
• Intervention / Treatment: Diagnostic test: [18F]fluoro-PEG-folate PET/CT scan

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-holland
    • Leiden, Zuid-holland, Netherlands, 2333 ZA
      • Katja Gaarenstroom

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [18F]fluoro-PEG-folate PET/CT scan; 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; A dynamic FR-targeted PET scan, a low-dose CT scan without contrast agents, and a static FR-targeted PET scan will be obtained

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Lioe-Fee de Geus-Oei, MD PhD
• Collaborators: Amsterdam UMC, location VUmc; The Netherlands Cancer Institute; Centre for Human Drug Research, Netherlands
• Investigators: Principal Investigator: Lioe-Fee de Geus-Oei, MD, PhD, LUMC

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2022
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: January 28, 2022
• First Posted (Actual): January 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
• Other Study ID Numbers: P20.048; 2020-000112-29 (EudraCT Number); NL72618.058.20 (Other Identifier: Medical ethical committee Leiden Den Haag Delft)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No