Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia

Fallopian Tube Cancer Clinical Trial

— OVANOX  

Official title:

Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04001023
• Other study ID #: 15867
• Status: Recruiting
• Phase: N/A
• Start date: March 9, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2019
• Source: Turku University Hospital
• Contact: Maren Laasik, MD
• Phone: +35823130000
• Email: maren.laasik[@]utu.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Finland	Turku University hospital	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	18F-EF5 maximum standardized uptake values (SUVmax)	Tumor and musculus gluteus maximus SUVmax ratio =1.5 is considered to refer to hypoxia	2-3 years
Secondary	Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue		2-3 years
Secondary	Disease-free survival		5 years
Secondary	Overall survival		5 years