Epithelial Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer
Conditions
Keywords
PET/CT, Ovarian cancer, HE4
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
Interventions
None listed
Sponsors
Turku University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 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 | 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 |
| Response to first line treatment: evaluation with PET/CT | PET/CT taken about 4 weeks after the last chemotherapy cycle | 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. |
| HE4 and CA125 in 1st relapse | Long time follow up ad 10 years | Prognostic value of HE4 and CA125 at 1st recurrence (defined with RECIST1.1. and GCIG criteria) is evaluated against post progression survival |
Countries
Finland
Outcome results
None listed