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

December 2, 2024 updated by: Turku University Hospital

Epithelial Ovarian Cancer- Staging and Response to Chemotherapy Evaluated by PET/CT(positron Emission Tomography/computed Tomography)

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

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Turku, Finland, 20521
        • Turku University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

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).
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.
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
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.
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)
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) 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
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.
PET/CT taken about 4 weeks after the last chemotherapy cycle
HE4 and CA125 in 1st relapse
Time Frame: 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
Long time follow up ad 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

  • Principal Investigator: Johanna Hynninen, MD, PhD, Turku University hospital, Department of Obstetrics and Gynecology
  • Study Director: Johanna Hynninen, Adj prof, Turku University hospital, Department of Obstetrics and Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

September 1, 2010

First Submitted That Met QC Criteria

January 12, 2011

First Posted (Estimated)

January 13, 2011

Study Record Updates

Last Update Posted (Actual)

December 4, 2024

Last Update Submitted That Met QC Criteria

December 2, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53/180/2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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