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

Epithelial Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05215496
• Other study ID #: P20.048
• Secondary ID: 2020-000112-29NL
• Status: Terminated
• Phase: Phase 1
• Start date: May 10, 2022
• Est. completion date: May 1, 2023

Study information

• Verified date: March 2024
• Source: Leiden University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: May 1, 2023
• Est. primary completion date: May 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Epithelial Ovarian Cancer
• Ovarian Neoplasms

Intervention

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

Locations

Country	Name	City	State
Netherlands	Katja Gaarenstroom	Leiden	Zuid-holland

Sponsors (4)

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

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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.
Primary	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.
Primary	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	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.