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

NCT05215496 | Terminated Phase 1 DMC

• 3 other identifiers: P20.0482020-000112-29NL72618.058.20
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Epithelial Ovarian Cancer

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Sensitivity and specificity

  Up to 6 weeks after the FR-targeted PET/CT scan.

Study Arms (1)

[18F]fluoro-PEG-folate PET/CT scan

EXPERIMENTAL

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

Interventions

[18F]fluoro-PEG-folate PET/CT scan DIAGNOSTIC_TEST

A dynamic FR-targeted PET scan, a low-dose CT scan without contrast agents, and a static FR-targeted PET scan will be obtained

[18F]fluoro-PEG-folate PET/CT scan

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with radiologically FIGO stage IIIB/IIIC EOC based on the conventional CT scan who are:
• scheduled to undergo primary cytoreductive surgery and
• in whom EOC is histologically proven, or
• in whom EOC is cytologically suspected and a serum CA125/CEA ratio \> 25 is found
• treated with neoadjuvant chemotherapy (NACT) and are scheduled to undergo interval cytoreductive surgery and
• in whom EOC is histologically proven, or
• in whom EOC is cytologically suspected and a serum CA125/CEA ratio \> 25 was found before NACT
• and with radiologically FIGO stage IIIB/IIIC EOC based on the response evaluation CT scan after NACT

You may not qualify if:

• 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)
• Patients who previously underwent primary laparotomy and in whom complete or optimal cytoreduction was not considered feasible.
• Contraindication for PET (pregnancy, lactating or severe claustrophobia)
• Thrombocytopenia (platelet count \< 100 x 10\^9/L) and/or INR \> 2
• Impaired renal function (defined as eGFR \< 50 mL/1.73 m2)
• Impaired liver function (ALT, AST or total bilirubin \> 3x upper limit of normal)
• Clinically significant abnormalities on ECG and/or clinically laboratory test
• Inability to tolerate lying supine for the duration of a PET/CT examination (\~110 minutes)
• 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
• Patients not able to comply with the study procedures
• Patients who did not give informed consent

Sponsors & Collaborators

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

Study Sites (1)

Katja Gaarenstroom

Leiden, South Holland, 2333 ZA, Netherlands

Location

Related Publications (1)

• Ciggaar 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 DERIVED

MeSH Terms

Conditions

Carcinoma, Ovarian Epithelial

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Lioe-Fee de Geus-Oei, MD, PhD

  LUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: January 31, 2022
• Study Start: May 10, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)