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

NCT02334371CompletedNAINTERVENTIONAL

Summary

Key Facts

Lead Sponsor

Maastricht University Medical Center

Enrollment

10

Start Date

2015-04-01

Completion Date

2016-03-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

MR-PET

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Diagnostic performance

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.

Time frame: 6 months

Locations

Maastricht University Medical Centre, Maastricht, Netherlands