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临床试验/NCT03808792
NCT03808792Unknown不适用

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

Charles University, Czech Republic1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2020年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
400
试验地点
1
主要终点
Preoperative identification of patients with ovarian/tubal cancer in whom optimal debulking (R0/R1) can not be achieved by US and CT scan.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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 <
  • ECOG (Eastern Cooperative Oncology Group) grade <
  • Patients after NACT can be included.

排除标准

  • 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

结局指标

主要结局

Preoperative identification of patients with ovarian/tubal cancer in whom optimal debulking (R0/R1) can not be achieved by US and CT scan.

时间窗: 24 months

Optimal debulking is defined as residual disease \<1cm

次要结局

  • Markers influencing accuracy - FIGO stage(24 months)
  • Markers influencing accuracy - Intraperitoneal fluid(24 months)
  • 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.(24 months)
  • Prediction model of achievement of optimal cytoreduction.(24 months)
  • Markers influencing accuracy - Histological type(24 months)
  • Markers influencing accuracy - Origin(24 months)
  • Markers influencing accuracy - Age(24 months)
  • Markers influencing accuracy - Postmenopausal status(24 months)
  • Markers influencing accuracy - Body mass index(24 months)
  • Markers influencing accuracy - CA 125(24 months)
  • Markers influencing accuracy - Image quality(24 months)

研究者

发起方
Charles University, Czech Republic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Patrícia Pinto

Principal Investigator

Charles University, Czech Republic

研究点 (1)

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