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

Primary Purpose

Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

Finland

Study Type

Interventional

Intervention

Imaging with 18F-EF5 PET/CT

About this trial

This is an interventional treatment trial for Epithelial Ovarian Cancer focused on measuring advanced ovarian cancer, EF5-PET/CT, hypoxia

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Turku University hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

PDS

IDS

Arm Description

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

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

Outcomes

Primary Outcome Measures

18F-EF5 maximum standardized uptake values (SUVmax)

Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia

Secondary Outcome Measures

Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue

Disease-free survival

Overall survival

Full Information

NCT ID

NCT04001023

First Posted

January 11, 2019

Last Updated

August 5, 2019

Sponsor

Turku University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04001023

Brief Title

Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia

Acronym

OVANOX

Official Title

Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2019

Overall Recruitment Status

Recruiting

Study Start Date

March 9, 2017 (Actual)

Primary Completion Date

December 31, 2022 (Anticipated)

Study Completion Date

December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Turku University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

advanced ovarian cancer, EF5-PET/CT, hypoxia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PDS

Arm Type

Experimental

Arm Description

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

Arm Title

IDS

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Imaging with 18F-EF5 PET/CT

Other Intervention Name(s)

Collection of targeted samples during surgery

Intervention Description

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

Primary Outcome Measure Information:

Title

18F-EF5 maximum standardized uptake values (SUVmax)

Description

Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia

Time Frame

2-3 years

Secondary Outcome Measure Information:

Title

Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue

Time Frame

2-3 years

Title

Disease-free survival

Time Frame

5 years

Title

Overall survival

Time Frame

5 years

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Maren Laasik, MD

Phone

+35823130000

maren.laasik@utu.fi

Facility Information:

Facility Name

Turku University hospital

City

Turku

ZIP/Postal Code

20521

Country

Finland

Individual Site Status

Recruiting

Facility Contact: