MR-PET for Staging and Assessment of Operability in Ovarian Cancer - a Feasibility Study

March 14, 2016 updated by: Iris Rutten, Maastricht University Medical Center
The importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. We believe that combined magnetic resonance imaging and positron emission tomography (MR-PET) can be of great clinical value in preoperative staging of patients with ovarian cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Recently, the academic hospital Maastricht invested in an integrated MR-PET system (Biograph mMR, Siemens Healthcare, Erlangen, Germany), ready to use for routine clinical application. Applications of this system are numerous and various types of cancer, including ovarian cancer, could benefit from the possibilities. The whole-body MR-PET system integrates the strengths of MRI and PET within a single examination. MRI provides anatomic detail in staging local tumor extent due to its high soft tissue resolution and advanced functional techniques such as DWI further enhance both local and distant lesion detection and characterisation. PET imaging complements this structural and functional information with molecular imaging technology useful in staging of adenopathy and metastatic spread. These characteristics contribute to a wide spectrum of possible clinical oncological applications, from primary tumor detection to local and distant staging, selection of patients for neoadjuvant therapy and assessment of response to chemotherapy and finally evaluation of recurrent disease.

The importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. We believe that combined magnetic resonance imaging and positron emission tomography (MR-PET) can be of great clinical value in preoperative staging of patients with ovarian cancer. Both positron emission tomography (PET), computed tomography (CT) and magnetic resonance imaging (MRI) have proved to be useful in ovarian cancer staging but understaging due to difficulties in depicting peritoneal dissemination remains a great problem. In conclusion, the best method for staging ovarian cancer and assessing operability remains to be discovered, hence this study.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

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

  • Netherlands
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Centre

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Expected FIGO stage IIB-IV epithelial ovarian carcinoma
  • Scheduled for primary debulking or interval debulking surgery
  • Written informed consent

Exclusion Criteria:

  • Patients estimated to have more benefit from chemotherapy
  • Ineligibility to undergo MR-PET examination (Non-MR compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, metal splinters etcetera) or claustrophobia)
  • Pregnant or lactating patients.
  • Incapacitated subjects

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

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: MR-PET
Preoperative whole-body MR-PET with 18F-FDG
Radiation: MR-PET
The MR-PET will be performed with the Biograph mMR system (Siemens Healthcare, Erlangen, Germany). This system integrates a 3Tesla MRI and PET scan which makes simultaneous acquisition of whole-body MRI and PET images possible. The Biograph mMR holds the CE mark and was FDA approved in June 2011. The Biograph mMR is intended to be used in the Academical hospita! Maastricht for standard patient care. The radiotracer that will be used is 18F-Iabeled fluorodeoxyglucose (18F-FDG), according to standard PET -protocol.
Other Names:
  • MRI-PET
  • PET-MRI
  • PET-MR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic performance
Time Frame: 6 months
Diagnostic performance of MR-PET compared to CT for characterisation of primary tumour, detection of tumour sites in the peritoneal cavity, retroperitoneum or liver, detection of lymphadenopathy and distant metastases and assessment of tumour stage and operability.
6 months

Collaborators and Investigators

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

Sponsor

Maastricht University Medical Center

Investigators

  • Principal Investigator: Toon Van Gorp, Maastricht University Medical Centre

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

April 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 8, 2015

Study Record Updates

Last Update Posted (Estimate)

March 16, 2016

Last Update Submitted That Met QC Criteria

March 14, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL50080.068.14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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