Ovarian CancerISAACNCT03808792
Imaging Study in Advanced Ovarian Cancer
An observational study of Ovarian Cancer, run by Charles University, Czech Republic at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Ovarian Cancer
- What is being tested?
- Ultrasound, CT and WB-DWI/MRI
- How many people
- 400 participants
- Where
- 1 siteCzechia
- Study dates
- Jan 2020to 31 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Gynecologic Oncology Center in Prague
Prague, 15000
Daniela Fischerová, MD, PhD, +420603285097, daniela.fischerova@seznam.cz
About this study
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
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.
Read the 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.
- Conditions
- Ovarian Cancer
- Being tested
- Ultrasound, CT and WB-DWI/MRI
- Keywords
- Ovarian cancer, Ultrasound, CT, WB-DW/MRI, Imaging
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound, CT and WB-DWI/MRIDiagnostic test
Preoperative assessment with Ultrasound, CT and WB-DWI/MRI
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: Ultrasound, CT and WB-DWI/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 months
Secondary outcomes (11)
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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charles University, Czech Republic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Patrícia Pinto, Charles University, Czech Republic
- Investigators
- Daniela Fischerová, MD, PhD, Study chair, Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital in Prague and 1st Medical Faculty of the Charles University, Prague, Czech Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03808792
- Sponsor's protocol ID
- č.j. 29/18
- Acronym
- ISAAC
- Status last verified
- Jan 2019
- First submitted
- 28 Oct 2018
- Last updated
- 18 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fischerova D, Pinto P, Pesta M, Blasko M, Moruzzi MC, Testa AC, Franchi D, Chiappa V, Alcazar JL, Wiesnerova M, Cibula D, Valentin L; collaborators. Ultrasound examiners' ability to describe ovarian cancer spread using preacquired ultrasound videoclips from a selected patient sample with high prevalence of cancer spread. Ultrasound Obstet Gynecol. 2025 May;65(5):641-652. doi: 10.1002/uog.29208. Epub 2025 Apr 18.
PubMed 40247746Pinto P, Valentin L, Borcinova M, Wiesnerova M, Filip F, Burgetova A, Masek M, Lambert L, Chiappa V, Franchi D, Testa AC, Moro F, Avesani G, Panico C, Alessi S, Pricolo P, Vigorito R, Calareso G, Kocian R, Slama J, Fagotti A, Urbinati AMV, Signorelli M, Bertolina F, Cibula D, Fischerova D. Patient satisfaction with ultrasound, whole-body CT and whole-body diffusion-weighted MRI for pre-operative ovarian cancer staging: a multicenter prospective cross-sectional survey. Int J Gynecol Cancer. 2024 Jun 3;34(6):871-878. doi: 10.1136/ijgc-2023-005264.
PubMed 38531539
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03808792
- Acronym / sponsor ID
- ISAAC / č.j. 29/18
- Conditions
- Ovarian Cancer
- Keywords
- Ovarian cancer, Ultrasound, CT, WB-DW/MRI, Imaging
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Charles University, Czech RepublicUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ovarian cancer patients | – | Diagnostic Test: Ultrasound, CT and WB-DWI/MRIPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound, CT and WB-DWI/MRIPreoperative assessment with Ultrasound, CT and WB-DWI/MRI | Diagnostic test | Ovarian cancer patients |
Primary outcome
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
11 secondary outcomes
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.
Time frame: 24 months
Prediction model of achievement of optimal cytoreduction.
Time frame: 24 months
Markers influencing accuracy - FIGO stage
Time frame: 24 months
Markers influencing accuracy - Histological type
Time frame: 24 months
Markers influencing accuracy - Origin
Time frame: 24 months
Markers influencing accuracy - Intraperitoneal fluid
Time frame: 24 months
Markers influencing accuracy - Age
Time frame: 24 months
Markers influencing accuracy - CA 125
Time frame: 24 months
Markers influencing accuracy - Postmenopausal status
Time frame: 24 months
Markers influencing accuracy - Body mass index
Time frame: 24 months
Markers influencing accuracy - Image quality
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2019.
- Derived from this study: PubMed 40247746Fischerova D, Pinto P, Pesta M, Blasko M, Moruzzi MC, Testa AC, Franchi D, Chiappa V, Alcazar JL, Wiesnerova M, Cibula D, Valentin L; collaborators. Ultrasound examiners' ability to describe ovarian cancer spread using preacquired ultrasound videoclips from a selected patient sample with high prevalence of cancer spread. Ultrasound Obstet Gynecol. 2025 May;65(5):641-652. doi: 10.1002/uog.29208. Epub 2025 Apr 18.
- Derived from this study: PubMed 38531539Pinto P, Valentin L, Borcinova M, Wiesnerova M, Filip F, Burgetova A, Masek M, Lambert L, Chiappa V, Franchi D, Testa AC, Moro F, Avesani G, Panico C, Alessi S, Pricolo P, Vigorito R, Calareso G, Kocian R, Slama J, Fagotti A, Urbinati AMV, Signorelli M, Bertolina F, Cibula D, Fischerova D. Patient satisfaction with ultrasound, whole-body CT and whole-body diffusion-weighted MRI for pre-operative ovarian cancer staging: a multicenter prospective cross-sectional survey. Int J Gynecol Cancer. 2024 Jun 3;34(6):871-878. doi: 10.1136/ijgc-2023-005264.
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Ovarian Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Fischerová, MD, PhD study chair
Gynecologic Oncology Center, Department of Obstetrics and Gynecology, General University Hospital in Prague and 1st Medical Faculty of the Charles University, Prague, Czech Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Cancer, run by Charles University, Czech Republic at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrícia Pinto, MD (+351912414130, aplpinto@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03808792, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2019.