Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT

Study Overview
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Brief Summary
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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

Official Title
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Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(Positron Emission Tomography/Computed Tomography)

Conditions
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Epithelial Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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. | PET/CT, contrast-enhanced CT and surgical status and histopathological findings are compared 1 month after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neoadjuvant chemotherapy (NACT) response evaluation with PET/CT compared with contrast-enhanced CT after 3 cycles of chemotherapy | Fdg PET/CT and a contrast-enhanced CT are performed in a row at the time of diagnosis and repeated after 3 cycles of chemotherapy. Finding are compared with disease status in the interval debulking surgery evaluated by operator and histological specimen. | 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) | HE4 and CA125 are measured at the time of diagnosis, perioperatively, and at each chemotherapy cycle (6-9). Treatment outcome is evaluated with contrast-enhanced CT at the end of primary therapy. HE4 and CA125 are compared with each other in different treatment outcomes (complete response, partial response, stable disease and progression) and PFS and OS | From diagnosis until the end of EOC primary therapy, about 8 months | 
| Response to first line treatment: evaluation with PET/CT | Treatment outcome measured with RECIST 1.1 and GCIG criteria is compared with PET/CT results. The prognostic role of persistent metabolic activity in PET/CT is evaluated. | PET/CT taken about 4 weeks after the last chemotherapy cycle | 
| HE4 and CA125 in 1st relapse | Prognostic value of HE4 and CA125 at 1st recurrence (defined with RECIST1.1. and GCIG criteria) is evaluated against post progression survival | Long time follow up ad 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET/CT, Ovarian cancer, HE4