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Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT (Mupet)
This study is ongoing, but not recruiting participants.
Sponsor:
Turku University Hospital
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01276574
First received: September 1, 2010
Last updated: May 22, 2017
Last verified: May 2017
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Purpose
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
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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.
| Condition |
|---|
| Epithelial Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(Positron Emission Tomography/Computed Tomography) |
Resource links provided by NLM:
Genetics Home Reference related topics:
ovarian cancer
Genetic and Rare Diseases Information Center resources:
Ovarian Cancer
Ovarian Epithelial Cancer
Fallopian Tube Cancer
U.S. FDA Resources
Further study details as provided by Turku University Hospital:
Primary Outcome Measures:
- 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 Outcome Measures:
- 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
tumour samples, whole blood and serum samples
| Estimated Enrollment: | 150 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | December 2017 |
| Estimated Primary Completion Date: | December 2017 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years (Adult, Senior) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with clinical suspicion of advanced EOC referred to surgery to Turku University hospital.
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
- previous cancer
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01276574
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276574
Locations
| Finland | |
| Turku University hospital | |
| Turku, Finland, 20521 | |
Sponsors and Collaborators
Turku University Hospital
Investigators
| 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 |
More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Turku University Hospital |
| ClinicalTrials.gov Identifier: | NCT01276574 History of Changes |
| Other Study ID Numbers: |
53/180/2009 |
| Study First Received: | September 1, 2010 |
| Last Updated: | May 22, 2017 |
Keywords provided by Turku University Hospital:
|
PET/CT Ovarian cancer HE4 |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Fallopian Tube Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases |
Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Fallopian Tube Diseases Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on July 21, 2017