NCT04001023

Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Turku University Hospital · Other Government
• Sex: Female
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Epithelial Ovarian Cancer
• Fallopian Tube Cancer
• Peritoneal Carcinoma
• Hypoxia

Interventions

Type	Name	Description
DEVICE	Imaging with 18F-EF5 PET/CT	Both 18F-FDG PET/CT and 18F-EF5 PET/CT imaging are performed in 1) preoperative work-up to clarify the disease distribution, 2) before IDS to evaluate treatment response to NACT (IDS arm); targeted samples from hypoxic and non-hypoxic tumors are collected during surgery

Timeline

• Start date: 2017-03-09
• Primary completion: 2022-12-31
• Completion: 2025-12-31
• First posted: 2019-06-27
• Last updated: 2019-08-07

Locations

1 site across 1 country: Finland