Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia

Not Applicable

Recruiting

• Conditions: Hypoxia; Fallopian Tube Cancer; Peritoneal Carcinoma; Epithelial Ovarian Cancer
• Interventions: Device: Imaging with 18F-EF5 PET/CT

• Registration Number: NCT04001023
• Lead Sponsor: Turku University Hospital

Brief Summary

The goal of this non-randomized prospective study is to use 18F-EF5-PET/CT imaging to identify and locate intraabdominal hypoxic ovarian cancer lesions. With targeted surgical sampling, precisely obtain hypoxic and potentially chemoresistant cancer tissue for our analyses and identify key molecular differences between hypoxic and non-hypoxic tumors within the same patient.

A portion of advanced stage EOC are inoperable at diagnosis and can be treated with neoadjuvant chemotherapy (NACT) before surgery. This approach offers a unique opportunity to study how hypoxic tumor areas respond to treatment.

Detailed Description

MORE SPECIFIC AIMS

1. To validate the feasibility of PET-tracer EF5 in EOC imaging.

* Quantify the amount and exact locations of hypoxic tumors in EOC patients using herein developed protocol and tracers (18F-EF5 and 18F-FDG) in diagnostic and neoadjuvant settings.

* Measure the non-cancer related EF5 accumulation spots and establish the potential pitfalls in abdominal EF5 imaging

* Establish a method to verify hypoxic locations with 18F-EF5-PET/CT information during the operation.

* Develop and validate a model that predicts chemotherapy response based on functional imaging information.

2. To reveal hypoxia related alterations in collected tissue samples (i.e. altered DNA damage repair, altered mitochondrial respiratory functioning, overexpression of hypoxia response elements etc)

Study Timeline

• Study Start: 2017-03-09
• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-06-26
• Study First Posted: 2019-06-27
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-05
• Last Update Posted: 2019-08-07
• Primary Completion: 2022-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• newly diagnosed advanced epithelial ovarian, primary peritoneal or fallopian tube cancer.
• age 18-79 years
• informed concent

Exclusion Criteria

• previous cancer
• pregnancy or nursing

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PDS	Imaging with 18F-EF5 PET/CT	18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery
IDS	Imaging with 18F-EF5 PET/CT	18F-EF5 PET/CT and 18F-FDG PET/CT scans prior to diagnostic laparoscopy and after neoadjuvant chemotherapy before interval cytoreductive surgery . Targeted sample collection during diagnostic laparoscopy and interval cytoreductive surgery

Primary Outcome Measures

Name	Time	Method
18F-EF5 maximum standardized uptake values (SUVmax)	2-3 years	Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia

Secondary Outcome Measures

Name	Time	Method
Disease-free survival	5 years
Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue	2-3 years
Overall survival	5 years

Trial Locations

Locations (1)

Turku University hospital; 🇫🇮 Turku, Finland