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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON44242

Enrollment

Registered

2014-12-30

Start date

2015-04-10

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ovarian cancer ovarian neoplasm

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)