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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:
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01276574
First received: September 1, 2010
Last updated: May 20, 2015
Last verified: May 2015
History of Changes
  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

  • 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:

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, contrance-enhanced CT and surgical status and histopatholocical findings are compared 1 month after surgery ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)


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)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, MD, PhD Turku University hospital, Department of Obstetrics and Gynecology
Principal Investigator: Johanna Hynninen, MD Turku University hospital, Department of Obstetrics and Gynecology
  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 20, 2015
Health Authority: Finland: Ethics Committee

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 September 27, 2016