Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT (Mupet)
|ClinicalTrials.gov Identifier: NCT01276574|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2011
Last Update Posted : May 7, 2018
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)
- 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
- 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.
|Condition or disease|
|Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer|
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(Positron Emission Tomography/Computed Tomography)|
|Study Start Date :||October 2009|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
- 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.
- 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 ]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) [ Time Frame: 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)
- Response to first line treatment: evaluation with PET/CT [ Time Frame: 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.
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01276574
|Turku University hospital|
|Turku, Finland, 20521|
|Study Director:||Seija Grénman, professor||Turku University hospital, Department of Obstetrics and Gynecology|
|Principal Investigator:||Johanna Hynninen, MD, PhD||Turku University hospital, Department of Obstetrics and Gynecology|
|Principal Investigator:||Tuulia Vallius, MD||Turku University hospital, Dep of Ob/gyn and Dep of oncology|