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Imaging Study in Advanced Ovarian Cancer

NCT03808792UNKNOWNOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Charles University, Czech Republic

Enrollment

400

Start Date

2020-01-01

Completion Date

2022-12-01

Study Type

OBSERVATIONAL

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

Interventions

UltrasoundCT and WB-DWI/MRI

Conditions

Ovarian Cancer

Eligibility

Age Range

18 Years – 80 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

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

Time frame: 24 months

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.

1. Detection of involvement of individual sites relevant for clinical management: * Rectosigmoid * Colon (except ileocecum) * Ileocaecum * Lesser omentum * Small intestine * Liver * Diaphragm * Pleura 2. 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.

Time frame: 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).

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 24 months

Locations

Gynecologic Oncology Center in Prague, Prague, Czechia

Linked Papers

2025-04-18

Ultrasound examiners' ability to describe ovarian cancer spread using preacquired ultrasound videoclips from a selected patient sample with high prevalence of cancer spread

ABSTRACTObjectivesTo assess the ability, as well as factors affecting the ability, of ultrasound examiners with different levels of ultrasound experience to detect correctly infiltration of ovarian cancer in predefined anatomical locations, and to evaluate the inter‐rater agreement regarding the presence or absence of cancer infiltration, using preacquired ultrasound videoclips obtained in a selected patient sample with a high prevalence of cancer spread.MethodsThis study forms part of the Imaging Study in Advanced ovArian Cancer multicenter observational study (NCT03808792). Ultrasound videoclips showing assessment of infiltration of ovarian cancer were obtained by the principal investigator (an ultrasound expert, who did not participate in rating) at 19 predefined anatomical sites in the abdomen and pelvis, including five sites that, if infiltrated, would indicate tumor non‐resectability. For each site, there were 10 videoclips showing cancer infiltration and 10 showing no cancer infiltration. The reference standard was either findings at surgery with histological confirmation or response to chemotherapy. For statistical analysis, the 19 sites were grouped into four anatomical regions: pelvis, middle abdomen, upper abdomen and lymph nodes. The videoclips were assessed by raters comprising both senior gynecologists (mainly self‐trained expert ultrasound examiners who perform preoperative ultrasound assessment of ovarian cancer spread almost daily) and gynecologists who had undergone a minimum of 6 months' supervised training in the preoperative ultrasound assessment of ovarian cancer spread in a gynecological oncology center. The raters were classified as highly experienced or less experienced based on annual individual caseload and the number of years that they had been performing ultrasound evaluation of ovarian cancer spread. Raters were aware that for each site there would be 10 videoclips with and 10 without cancer infiltration. Each rater independently classified every videoclip as showing or not showing cancer infiltration and rated the image quality (on a scale from 0 to 10) and their diagnostic confidence (on a scale from 0 to 10). A generalized linear mixed model with random effects was used to estimate which factors (including level of experience, image quality, diagnostic confidence and anatomical region) affected the likelihood of a correct classification of cancer infiltration. We assessed the observed percentage of videoclips classified correctly, the expected percentage of videoclips classified correctly based on the generalized linear mixed model and inter‐rater agreement (reliability) in classifying anatomical sites as being infiltrated by cancer.ResultsTwenty‐five raters participated in the study, of whom 13 were highly experienced and 12 were less experienced. The observed percentage of correct classification of cancer infiltration ranged from 70% to 100% depending on rater and anatomical site, and the median percentage of correct classification for the 25 raters ranged from 90% to 100%. The probability of correct classification of all 380 videoclips ranged from 0.956 to 0.975 and was not affected by the rater's level of ultrasound experience. The likelihood of correct classification increased with increased image quality and diagnostic confidence and was affected by anatomical region. It was highest for sites in the pelvis, second highest for those in the middle abdomen, third highest for lymph nodes and lowest for sites in the upper abdomen. The inter‐rater agreement of all 25 raters regarding the presence of cancer infiltration ranged from substantial (Fleiss kappa, 0.68 (95% CI, 0.66–0.71)) to very good (Fleiss kappa, 0.99 (95% CI, 0.97–1.00)) depending on the anatomical site. It was lowest for sites in the upper abdomen (Fleiss kappa, 0.68 (95% CI, 0.66–0.71) to 0.97 (95% CI, 0.94–0.99)) and highest for sites in the pelvis (Fleiss kappa, 0.94 (95% CI, 0.92–0.97) to 0.99 (95% CI, 0.97–1.00)).ConclusionsUltrasound examiners with different levels of ultrasound experience can classify correctly predefined anatomical sites as being infiltrated or not infiltrated by ovarian cancer based on video recordings obtained by an experienced ultrasound examiner, and the inter‐rater agreement is substantial. The likelihood of correct classification as well as the inter‐rater agreement is highest for sites in the pelvis and lowest for sites in the upper abdomen. However, owing to the study design, our results regarding diagnostic accuracy and inter‐rater agreement are likely to be overoptimistic. © 2025 The Author(s). Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.

2024-06-03

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

In addition to the diagnostic accuracy of imaging methods, patient-reported satisfaction with imaging methods is important. To report a secondary outcome of the prospective international multicenter Imaging Study in Advanced ovArian Cancer (ISAAC Study), detailing patients' experience with abdomino-pelvic ultrasound, whole-body contrast-enhanced computed tomography (CT), and whole-body diffusion-weighted magnetic resonance imaging (WB-DWI/MRI) for pre-operative ovarian cancer work-up. In total, 144 patients with suspected ovarian cancer at four institutions in two countries (Italy, Czech Republic) underwent ultrasound, CT, and WB-DWI/MRI for pre-operative work-up between January 2020 and November 2022. After having undergone all three examinations, the patients filled in a questionnaire evaluating their overall experience and experience in five domains: preparation before the examination, duration of examination, noise during the procedure, radiation load of CT, and surrounding space. Pain perception, examination-related patient-perceived unexpected, unpleasant, or dangerous events ('adverse events'), and preferred method were also noted. Ultrasound was the preferred method by 49% (70/144) of responders, followed by CT (38%, 55/144), and WB-DWI/MRI (13%, 19/144) (p7 of 10) during the ultrasound examination. We did not identify any factors related to patients' preferred method. Ultrasound was the imaging method preferred by most patients despite being associated with more pain during the examination in comparison with CT and WB-DWI/MRI. NCT03808792.

Linked Investigators

A. C. Testa

Daniela Fischerova

David Cibula

D. Franchi

Francesca Moro

Giacomo Avesani

Juan Luis Alcázar

L. Valentin

Martina Borčinová

M. Blasko

M. Pesta

Patrícia Pinto

Valentina Chiappa