Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(positron Emission Tomography/computed Tomography)

Turku University Hospital1 site in 1 country150 target enrollmentOctober 2009

ConditionsEpithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Epithelial Ovarian Cancer
Sponsor: Turku University Hospital
Enrollment: 150
Locations: 1
Primary Endpoint: 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).
Status: Active, not recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

December 31, 2024

Last Updated

last year

Study Type

Observational

Sex

Female

Investigators

Sponsor

Turku University Hospital

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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).

Time Frame: PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery

Patient is scanned with whole body Fdg PET/CT and contrast-enhanced CT in a row within 3 weeks preoperatively. Findings are compared with intraoperative surgical status evaluated by operator and confirmed with biopsies.

Secondary Outcomes

Serial measurement of HE4 (human epididymis protein 4) and CA125 (cancer antigen 125)during primary treatment of EOC (Epithelial ovarian cancer)(From diagnosis until the end of EOC primary therapy, about 8 months)
Neoadjuvant chemotherapy (NACT) response evaluation with PET/CT compared with contrast-enhanced CT after 3 cycles of chemotherapy(Outcome measure: after interval debulking surgery, about 4 months)
Response to first line treatment: evaluation with PET/CT(PET/CT taken about 4 weeks after the last chemotherapy cycle)
HE4 and CA125 in 1st relapse(Long time follow up ad 10 years)