Imaging Study in Advanced Ovarian Cancer

NCT ID: NCT03808792

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2022-12-31

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.

Conditions

Ovarian Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

Ultrasound, CT and WB-DWI/MRI

Intervention Type: DIAGNOSTIC_TEST

Preoperative assessment with Ultrasound, CT and WB-DWI/MRI

Interventions

Ultrasound, CT and WB-DWI/MRI

Preoperative assessment with Ultrasound, CT and WB-DWI/MRI

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Abdominal or pelvic mass suspicious of primary ovarian, tubal or peritoneal cancer using subjective assessment by experienced sonographer.

2. Surgery (PDS or IDS) within 4 weeks from the index test.

3. 18 > Age < 80.

4. ECOG (Eastern Cooperative Oncology Group) grade < 3.

5. Patients after NACT can be included.

Exclusion Criteria

1. Lesions suspected as being borderline ovarian tumors (BOT) on ultrasound.

2. Patients with supradiaphragmatic metastases

3. Contraindications to CT

4. Medical contraindications to surgery

5. Refusal or withdrawal of written informed consent

6. Time lapse between ultrasound and surgery more than 4 weeks

7. Current pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

Ana Patrícia Pinto

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Daniela Fischerová, MD, PhD

Role: 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

Locations

Gynecologic Oncology Center in Prague

Prague, , Czechia

Countries

Czechia

Central Contacts

Patrícia Pinto, MD

Role: CONTACT

aplpinto@gmail.com

+351912414130

Daniela Fischerová, MD, PhD

Role: CONTACT

daniela.fischerova@seznam.cz

+420603285097

Facility Contacts

Daniela Fischerová, MD, PhD

Role: primary

daniela.fischerova@seznam.cz

+420603285097

References

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.

Reference Type: DERIVED

PMID: 40247746 (View on PubMed)

Pinto 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.

Reference Type: DERIVED

PMID: 38531539 (View on PubMed)

Other Identifiers

č.j. 29/18

Identifier Type: -

Identifier Source: org_study_id