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

Sponsor
Lioe-Fee de Geus-Oei, MD PhD (Other)
Overall Status
Recruiting
CT.gov ID
NCT05215496
Collaborator
Amsterdam UMC, location VUmc (Other), Centre for Human Drug Research, Netherlands (Other), The Netherlands Cancer Institute (Other)
15
Enrollment
1
Location
1
Arm
6.5
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: [18F]fluoro-PEG-folate PET/CT scan
 Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
185 MBq of [18F]fluoro-PEG-folate PET tracer will be intravenously administered to 15 patients with radiologically advanced stage EOC who are scheduled to undergo cytoreductive surgery, after which an FR-targeted PET/CT will be made. FR-targeted PET/Ct results will be compared to the intraoperative findings, postoperative histopathology (gold standard) and the conventional CT scan.185 MBq of [18F]fluoro-PEG-folate PET tracer will be intravenously administered to 15 patients with radiologically advanced stage EOC who are scheduled to undergo cytoreductive surgery, after which an FR-targeted PET/CT will be made. FR-targeted PET/Ct results will be compared to the intraoperative findings, postoperative histopathology (gold standard) and the conventional CT scan.
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
[18F]Fluoro-PEG-folate PET/CT Imaging in Epithelial Ovarian Cancer
Actual Study Start Date :
May 10, 2022
Anticipated Primary Completion Date :
Nov 25, 2022
Anticipated Study Completion Date :
Nov 25, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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.

  2. 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.

  3. 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.

  4. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Leiden University Medical Center Leiden Zuid-holland Netherlands 2333 ZA

Sponsors and Collaborators

  • Lioe-Fee de Geus-Oei, MD PhD
  • Amsterdam UMC, location VUmc
  • Centre for Human Drug Research, Netherlands
  • The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Lieo-Fee de Geus-Oei, MD, PhD, LUMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lioe-Fee de Geus-Oei, MD PhD, Principal Investigator, Leiden University Medical Center
ClinicalTrials.gov Identifier:
NCT05215496
Other Study ID Numbers:
  • P20.048
  • 2020-000112-29
  • NL72618.058.20
First Posted:
Jan 31, 2022
Last Update Posted:
Aug 18, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:
Ovarian Neoplasms
Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Aug 18, 2022