Imaging Study in Advanced Ovarian Cancer

Study Overview
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Brief Summary
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The aim of the study is the assessment of tumour sites critical for the achievement of optimal cytoreduction in patients with advanced ovarian cancer using Ultrasound, CT and WB-DWI/MRI. The study uses an equivalence design with a hypothesis that cases with non-resectable disease identified by Index test (Ultrasound, CT and WB-DWI MRI) are equivalent to a portion of cases identified during surgery.

Detailed Description
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Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer using subjective assessment by experienced sonographer (principal investigator) will be enrolled in the study and send to surgical planning. During surgical planning, the CT and MRI will be scheduled and the patient ́s consent will be requested if inclusion criteria are fulfilled. Please note, tumors with atypical morphology and/or tumor spread suspicious for secondary ovarian cancer will be first subjected to a tru-cut biopsy and will be included if histopathology confirms adnexal or peritoneal cancer. Ultrasound will be always performed by the principal investigator in each center. Principal investigator is an ultrasound expert with level II or III EFSUMB accreditation (http://www.efsumb.org/). Operators performing ultrasound scan and radiologists performing CT or MRI will be well instructed and educated about standardized approach and criteria of inoperability. Sonographers and radiologists will be blinded to the results of other imaging modalities. If a patient already had CT or WB-DWI/MRI done by the referring hospital, the study radiologists will decide about the quality of imaging and necessity to repeat CT or WB-DWI/MRI. The decision to treat by PDS (primary debulking surgery), or by NACT (neoadjuvant chemotherapy) with IDS (interval debulking surgery) will be based on departmental guidelines taking into account medical comorbidities and disease-related factors. If a patient is indicated for NACT a tru-cut biopsy or/and a diagnostic laparoscopy are performed. The clinicians will document why the primary debulking surgery was not considered. The surgery (laparoscopy, primary or interval debulking surgery) should always be performed within four weeks after the index test. Patients without surgical exploration will be excluded. Surgeons performing laparoscopy will describe site to site involvement and in case of inoperability will take a biopsy and document reasons for abandoning laparotomy. In operable cases surgeons performing laparotomy will describe site to site involvement and where applicable reasons for not achieving optimal cytoreduction defined as no residual tumor left in situ at the end of surgery (R0). If the patient has only ultrasound and CT (and not WB-DWI/MRI) she can still be included in the study. Similarly if the patient undergoes interval debulking surgery she can be included in the study if the index tests will be performed less than 4 week before IDS. Clinical data and four evaluation forms will be filled in (Ultrasound, CT, MRI, Surgery) immediately after the procedure using electronic database. The evaluation form from histopathology will be filled when available by principal investigator. The database cannot be saved unless all the information required are filled in and it will not be available to any other investigator. Data will be submitted for statistical analysis.

Official Title
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A Comparison Between Ultrasound, CT (CT) and Whole-body Diffusion-weighted MRI (WB-DWI/MRI) in the Assessment of Operability in Patients With Ovarian Cancer

Conditions
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Ovarian Cancer

Intervention / Treatment
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* Diagnostic Test: Ultrasound, CT and WB-DWI/MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer using subjective assessment by experienced sonographer. Surgery (PDS or IDS) within 4 weeks from the index test. 18 > Age < 80. ECOG (Eastern Cooperative Oncology Group) grade < 3. Patients after NACT can be included. Exclusion Criteria: Lesions suspected as being borderline ovarian tumors (BOT) on ultrasound. Patients with supradiaphragmatic metastases Contraindications to CT Medical contraindications to surgery Refusal or withdrawal of written informed consent Time lapse between ultrasound and surgery more than 4 weeks Current pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovarian cancer patients<br>Patients with abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer submitted to the index test (Ultrasound, CT and WB/DWI-MRI) with perspective of primary surgery | Diagnostic Test: Ultrasound, CT and WB-DWI/MRI<br>* Preoperative assessment with Ultrasound, CT and WB-DWI/MRI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preoperative identification of patients with ovarian/tubal cancer in whom optimal debulking (R0/R1) can not be achieved by US and CT scan. | Optimal debulking is defined as residual disease <1cm | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the diagnostic performance in the detection of involvement of individual sites relevant for clinical management and in the detection of 24 individual sites described in the evaluation form. | Detection of involvement of individual sites relevant for clinical management: Rectosigmoid Colon (except ileocecum) Ileocaecum Lesser omentum Small intestine Liver Diaphragm Pleura Detection of 24 individual sites described in the evaluation form (17 peritoneal sites and 7 lymph nodes sites). The aim is to clarify the diagnostic performance of the different imaging methods in the assessment of tumor extent in form of peritoneal carcinomatosis and metastatic lymph nodes. The investigators want to establish the overall accuracy of each imaging modality in all the metastatic sites. The major interest lies in the sites that determine the extent of surgery and optimal cytoreduction, in particular bowel resection, lesser omentum, superficial liver metastases, diaphragm or pleura. | 24 months | 
| Prediction model of achievement of optimal cytoreduction. | Prediction of optimal cytoreduction based on preoperative imaging. Optimal cytoreduction is defined as no residual tumor left at the end of surgery (R0). | 24 months | 
| Markers influencing accuracy - FIGO stage | Assessment of markers influencing diagnostic accuracy of individual methods: FIGO stage - it will be analised if the accuracy of the imaging methods change between early stages (I-II) and late stages (III-IV) of the disease | 24 months | 
| Markers influencing accuracy - Histological type | Assessment of markers influencing diagnostic accuracy of individual methods: Histological type - it will be analised if the accuracy of the imaging methods change between serous type and other histological types | 24 months | 
| Markers influencing accuracy - Origin | Assessment of markers influencing diagnostic accuracy of individual methods: Origin - it will be analised if the accuracy of the imaging methods change between ovarian origin and tubal origin | 24 months | 
| Markers influencing accuracy - Intraperitoneal fluid | Assessment of markers influencing diagnostic accuracy of individual methods: Intraperitoenal fluid - it will be analised if the accuracy of the imaging methods change between < or = 400 mL and > 400 mL | 24 months | 
| Markers influencing accuracy - Age | Assessment of markers influencing diagnostic accuracy of individual methods: Age - it will be analised if the accuracy of the imaging methods change between women with < or = 65 and > 65 years old | 24 months | 
| Markers influencing accuracy - CA 125 | Assessment of markers influencing diagnostic accuracy of individual methods: CA 125 - it will be analised if the accuracy of the imaging methods change between < or = 300 U/mL and > 300 U/mL | 24 months | 
| Markers influencing accuracy - Postmenopausal status | Assessment of markers influencing diagnostic accuracy of individual methods: Postmenopausal status - it will be analised if the accuracy of the imaging methods change between premnopausal and postmenopausal status | 24 months | 
| Markers influencing accuracy - Body mass index | Assessment of markers influencing diagnostic accuracy of individual methods: Body mass índex - it will be analised if the accuracy of the imaging methods change between < or = 25 kg/m2 and > 25 kg/m2 | 24 months | 
| Markers influencing accuracy - Image quality | Assessment of markers influencing diagnostic accuracy of individual methods: Image quality - it will be analised if the accuracy of the imaging methods change between good, moderate and poor image quality | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ovarian cancer, Ultrasound, CT, WB-DW/MRI, Imaging