Study Into a New Diagnostic Tool (Simple Ultrasound-based Rules) in Patients With Adnexal Masses

Summary

This study is performed to compare the diagnostic performance and cost-effectiveness of different diagnostic methods for differentiating benign from malignant adnexal (ovary or Fallopian tube) masses: the Risk of Malignancy Index (RMI) will be compared with a two-step triage test called "simple ultrasound-based rules" supplemented -if necessary- with either subjective assessment by an expert sonographer or Diffusion Weighted - Magnetic Resonance Imaging (DW-MRI). The investigators will test the hypothesis that this two-step triage test will have better diagnostic accuracy than the RMI and therefore will improve the management of women with adnexal masses.

Conditions

• Ovarian Carcinoma
• Ovarian Cancer
• Ovarian Mass
• Ovarian Cyst

Interventions

OTHER

Ultrasound by general gynaecologist

All patients will undergo an ultrasound by a general gynaecologist at the moment of inclusion. Based on this ultrasound, the gynaecologist will use both the RMI and the simple rules to predict the chance of malignancy.

OTHER

Ultrasound by an expert ultrasonographist

Patients in which the simple rules yield an inconclusive result (about 20% of all patients) will undergo a second ultrasound scan. This scan is performed by an expert in gynaecological ultrasound.

OTHER

DW-MRI

Patients in which the simple rules yield an inconclusive result (about 20% of all patients) will undergo a diffusion weighted MRI.

OTHER

Give blood sample

Patients in which the simple rules yield an inconclusive result (about 20% of the patients) will be asked for an extra blood sample. We will use these materials to perform translational research and validate new biomarkers in the diagnosis of ovarian cancer.

Sponsors & Collaborators

• Laurentius Hospital Roermond

  collaborator UNKNOWN

• St.Jans Gasthuis Weert

  collaborator UNKNOWN

• VieCuri Medical Centre

  collaborator OTHER

• Orbis Medical Centre

  collaborator OTHER

• Maastricht University Medical Center

  lead OTHER

Principal Investigators

• Evelyne MJ Meys, LLM, BsC · Maastricht University Medical Center

• Toon van Gorp, MD, PhD · Maastricht University Medical Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2015-09-30

Completion

2015-10-01

Countries

• Netherlands

Study Locations