Brief Title
Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT
Official Title
Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(Positron Emission Tomography/Computed Tomography)
Brief Summary
The purpose of this study is to determine, whether there is clinical benefit of using fdg-PET/CT (F-18-fluorodeoxyglucose- positron emission tomography/computed tomography)compared to contrast-enhanced CT in primary treatment of advanced epithelial ovarian cancer (EOC) - Objectives - the impact of preoperative PET/CT compared to CT on EOC stage definition - to compare the value of preoperative PET/CT, CT and laparoscopy in intra-abdominal tumour assessment. Laparotomy findings evaluated by surgeon and histopathologic results serve as the reference standard. - to compare serum markers HE4(human epididymis protein 4) and CA125 (cancer antigen 125) with FDG-PET/CT and CT in treatment response evaluation during neoadjuvant chemotherapy and primary treatment of EOC - to compare FDG PET/CT based treatment response evaluation with RECIST and GCIG criteria - Methods - All the patients will undergo FDG-PET/CT prior surgery, after possible neoadjuvant chemotherapy (NACT) and 4 weeks after completion of primary platinum-based chemotherapy. - CA125 and HE4 levels are measured pre-operatively, with every chemotherapy cycle and regularly during follow-up until 1st disease relapse
Study Type
Observational
Primary Outcome
PET/CT (positron emission tomography/computed tomography)compared with contrast-enhanced CT in preoperative evaluation of disease burden in patients with advanced Epithelial ovarian cancer (EOC).
Secondary Outcome
Neoadjuvant chemotherapy (NACT) response evaluation with PET/CT compared with contrast-enhanced CT after 3 cycles of chemotherapy
Condition
Epithelial Ovarian Cancer
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
150
Start Date
October 2009
Completion Date
December 31, 2022
Primary Completion Date
December 31, 2022
Eligibility Criteria
Inclusion Criteria: - Newly diagnosed patients with advanced epithelial ovarian, primary peritoneal cancer or fallopian tube cancer. - age 18-79 years - informed concent Exclusion Criteria: - diabetes (for PET/CT analyses) - previous cancer
Gender
Female
Ages
18 Years - 79 Years
Accepts Healthy Volunteers
No
Contacts
Seija Grénman, professor, ,
Location Countries
Finland
Location Countries
Finland
Administrative Informations
NCT ID
NCT01276574
Organization ID
53/180/2009
Responsible Party
Sponsor
Study Sponsor
Turku University Hospital
Study Sponsor
Seija Grénman, professor, Study Director, Turku University hospital, Department of Obstetrics and Gynecology
Verification Date
April 2022