Imaging Study in Advanced Ovarian Cancer

Ovarian Cancer Clinical Trial

— ISAAC  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03808792
• Other study ID #: c.j. 29/18
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2019
• Source: Charles University, Czech Republic
• Contact: Patrícia Pinto, MD
• Phone: +351912414130
• Email: aplpinto[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: December 31, 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms

Intervention

Diagnostic Test:
• Ultrasound, CT and WB-DWI/MRI
Preoperative assessment with Ultrasound, CT and WB-DWI/MRI

Locations

Country	Name	City	State
Czechia	Gynecologic Oncology Center in Prague	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient Method Friendly Questionnaire	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)	24 months
Other	Excluded patients	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: Age <18 or > 80 years old; Poor performance status ECOG >3; Histologic report of biopsy of a non-gynecologic cancer; Contraindications to upfront LPS or LPT (only tru-cut biopsy +/- NACT); Contraindications to CT; Consent not given by the patient (denial or withdrawal of oral informed consent); Absence of insurance; Time between ultrasound and surgery more than 4 weeks; Current pregnancy; Death; Others, please specify:	24 months
Other	Record of choice of treatment	Record of multidisciplinary team choice of primary surgery or neoadjuvant chemotherapy to clarify personal and external factors in decision making	24 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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