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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-10

Study Completion Date

2023-05-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Epithelial Ovarian Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

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

Group Type EXPERIMENTAL

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

Intervention Type 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

Interventions

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[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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

30 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No