MR-PET for staging and assessment of operability in ovarian cancer * a feasibility study

Completed

• Conditions: 10038594; ovarian cancer; ovarian neoplasm

• Registration Number: NL-OMON44242
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2016-04-22
• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

Expected FIGO stage IIB-IV epithelial ovarian carcinoma
Scheduled for primary debulking surgery or interval debulking surgery
Written informed consent
At least 18 years of age.

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Main study parameter will be the diagnostic performance of MR-PET in<br /><br>preoperative staging and evaluation of operability of women with advanced stage<br /><br>epithelial ovarian cancer. Different anatomical sites will be evaluated<br /><br>systematically. Numbers of true positive (TP), false positive (FP), true<br /><br>negative (TN) and false negative (FN) will be recorded for each item from which<br /><br>sensitivity, specificity, positive predictive value, negative predictive value<br /><br>and accuracy will be calculated. The index test (MR-PET) will be compared to<br /><br>the current imaging modality of choice in clinical practice (CT). Surgical<br /><br>staging and histopathology will be used as the reference standard. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>NA</p><br>