Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia (OVANOX)

Turku University Hospital (TYKS)

Status: Enrolling

Conditions: Epithelial Ovarian Cancer; Hypoxia; Fallopian Tube Cancer; Peritoneal Carcinoma

Treatments: Device: Imaging with 18F-EF5 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT04001023

15867

Details and patient eligibility

About

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.

Full 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)

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 79 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

PDS

Experimental group

Description:

18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery

Treatment:

Device: Imaging with 18F-EF5 PET/CT

IDS

Experimental group

Description:

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

Treatment:

Device: Imaging with 18F-EF5 PET/CT