Condition or disease | Intervention/treatment |
---|---|
Ovarian Cancer | Diagnostic Test: Ultrasound, CT and WB-DWI/MRI |
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.
Study Type : | Observational |
Estimated Enrollment : | 400 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Estimated Study Start Date : | January 2020 |
Estimated Primary Completion Date : | December 2022 |
Estimated Study Completion Date : | December 31, 2022 |
Group/Cohort | Intervention/treatment |
---|---|
Ovarian cancer patients
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
Preoperative assessment with Ultrasound, CT and WB-DWI/MRI
|
Detection of involvement of individual sites relevant for clinical management:
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.
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
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
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
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
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
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
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
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
Evaluation of patients' experience of the imaging modalities using Patient Method Friendly Questionnaire.
The aim of the questionnaire is to evaluate the overall experience through the different imaging methods and to evaluate relevant factors that may had a negative impact on the examination. The answers should be in a 4-point scale (1-very disappointing; 2-disappointing; 3- satisfied; 4-very satisfied) except the level of pain that should be in a 10-scale of pain (1 - no pain; 10 - maximum pain)
Monitorization of excluded patients using an evaluation form filled by the principal investigator or study coordinator in each center. It has to be chosen one of the next options:
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Female patients |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Contact: Patrícia Pinto, MD | +351912414130 | aplpinto@gmail.com | |
Contact: Daniela Fischerová, MD, PhD | +420603285097 | daniela.fischerova@seznam.cz |
Czechia | |
Gynecologic Oncology Center in Prague | |
Prague, Czechia, 15000 | |
Contact: Daniela Fischerová, MD, PhD +420603285097 daniela.fischerova@seznam.cz |
Study Chair: | Daniela Fischerová, MD, PhD | Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital in Prague and 1st Medical Faculty of the Charles University, Prague, Czech Republic |
Tracking Information | |||||||||
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First Submitted Date | October 28, 2018 | ||||||||
First Posted Date | January 18, 2019 | ||||||||
Last Update Posted Date | January 18, 2019 | ||||||||
Estimated Study Start Date | January 2020 | ||||||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures |
Preoperative identification of patients with ovarian/tubal cancer in whom optimal debulking (R0/R1) can not be achieved by US and CT scan. [ Time Frame: 24 months ] Optimal debulking is defined as residual disease <1cm
|
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Original Primary Outcome Measures | Same as current | ||||||||
Change History | No Changes Posted | ||||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||||
Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title | Imaging Study in Advanced Ovarian Cancer | ||||||||
Official Title | 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 | ||||||||
Brief Summary | 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 |
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. |
||||||||
Study Type | Observational | ||||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||||||
Target Follow-Up Duration | Not Provided | ||||||||
Biospecimen | Not Provided | ||||||||
Sampling Method | Non-Probability Sample | ||||||||
Study Population | Patients with an abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer | ||||||||
Condition | Ovarian Cancer | ||||||||
Intervention | Diagnostic Test: Ultrasound, CT and WB-DWI/MRI
Preoperative assessment with Ultrasound, CT and WB-DWI/MRI
|
||||||||
Study Groups/Cohorts | Ovarian cancer patients
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
Intervention: Diagnostic Test: Ultrasound, CT and WB-DWI/MRI
|
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status | Not yet recruiting | ||||||||
Estimated Enrollment |
400 | ||||||||
Original Estimated Enrollment | Same as current | ||||||||
Estimated Study Completion Date | December 31, 2022 | ||||||||
Estimated Primary Completion Date | December 2022 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 80 Years (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts |
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Listed Location Countries | Czechia | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number | NCT03808792 | ||||||||
Other Study ID Numbers | č.j. 29/18 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||||
Responsible Party | Ana Patrícia Pinto, Charles University, Czech Republic | ||||||||
Study Sponsor | Charles University, Czech Republic | ||||||||
Collaborators | Not Provided | ||||||||
Investigators |
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PRS Account | Charles University, Czech Republic | ||||||||
Verification Date | January 2019 |