Brief Title
Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia
Official Title
Overcoming Chemoresistance in Advanced Ovarian Cancer Via Targeting Hypoxia
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 Type
Interventional
Primary Outcome
18F-EF5 maximum standardized uptake values (SUVmax)
Secondary Outcome
Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue
Condition
Epithelial Ovarian Cancer
Intervention
Imaging with 18F-EF5 PET/CT
Study Arms / Comparison Groups
PDS
Description: 18F-EF5 PET/CT and 18F-FDG PET/CT scan prior to primary cytoreductive surgery and targeted sample collection during primary cytoreductive surgery
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
40
Start Date
March 9, 2017
Completion Date
December 31, 2025
Primary Completion Date
December 31, 2022
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
Gender
Female
Ages
18 Years - 79 Years
Accepts Healthy Volunteers
No
Contacts
, +35823130000, [email protected]
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT04001023
Organization ID
15867
Responsible Party
Sponsor
Study Sponsor
Turku University Hospital
Study Sponsor
, ,
Verification Date
August 2019