Epithelial Ovarian Cancer, Fallopian Tube Cancer, Hypoxia, Peritoneal Carcinoma
Conditions
Keywords
advanced ovarian cancer, EF5-PET/CT, 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)
Interventions
DEVICEImaging 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
Sponsors
Turku University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 18F-EF5 maximum standardized uptake values (SUVmax) | 2-3 years | Tumor and musculus gluteus maximus SUVmax ratio ≥1.5 is considered to refer to hypoxia |
Secondary
| Measure | Time frame |
|---|---|
| Correlation between the uptake of 18F-EF5 isotope in PET/CT and immunohistochemical profile of tumor tissue | 2-3 years |
| Disease-free survival | 5 years |
| Overall survival | 5 years |
Countries
Finland
Contacts
Primary ContactMaren Laasik, MD
Outcome results
None listed