This trial is active, not recruiting.

Conditions epithelial ovarian cancer, peritoneal cancer, fallopian tube cancer
Sponsor Turku University Hospital
Start date October 2009
End date December 2017
Trial size 150 participants
Trial identifier NCT01276574, 53/180/2009


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

- 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 and with every chemotherapy cycle.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective

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

Secondary Outcomes

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

Eligibility Criteria

Female participants from 18 years up to 79 years old.

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 - previous cancer

Additional Information

Official title Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(Positron Emission Tomography/Computed Tomography)
Principal investigator Johanna Hynninen, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Turku University Hospital.