Clinical Trial · NCT05215496

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

Overview

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.

Sponsor

Leiden University Medical Center

Phase

Phase 1

Contacts

Lioe-Fee de Geus-Oei, MD, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05215496

Eligibility

Inclusion

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

Exclusion

Clinically significant abnormalities on ECG and/or clinically laboratory test
Impaired liver function (ALT, AST or total bilirubin \> 3x upper limit of normal)
Thrombocytopenia (platelet count \< 100 x 10\^9/L) and/or INR \> 2
Impaired renal function (defined as eGFR \< 50 mL/1.73 m2)
Patients who previously underwent primary laparotomy and in whom complete or optimal cytoreduction was not considered feasible.