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Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer (S53580)

Primary Purpose

Ovarian Carcinoma

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Whole body diffusion-weighted MRI
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ovarian Carcinoma focused on measuring Ovarian carcinoma, Staging, Early treatment follow-up, Identifying tumor recurrence, Whole body diffusion-weighted MRI

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • STAGING: patients with suspected ovarian carcinoma
  • EARLY TREATMENT ASSESSMENT: patients with FIGO stage IIIc or IV ovarian carcinoma who will undergo neoadjuvant chemotherapy
  • IDENTIFYING TUMOR RECURRENCE: patients with a medical history of ovarian carcinoma with suspicion of recurrent ovarian cancer after a disease-free-interval of at least 6 months

Exclusion Criteria:

  • patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients)will be excluded from this study.
  • patients with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR < 30 mL/min)and/or Buscopan

Sites / Locations

  • University Hospitals UZ Leuven, Gasthuisberg

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Not applicable (imaging study)

Arm Description

Outcomes

Primary Outcome Measures

Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
WB-DWI for tumor characterization and staging at primary diagnosis
The aim of this part of the study is to prospectively evaluate WB-DWI for tumor characterization and staging at primary diagnosis in comparison to CT and combined CT/diagnostic laparoscopy with the aim to assess patient operability.
WB-DWI for response assessment during and early after neoadjuvant chemotherapy
The aim of this part of the study is to prospectively evaluate WB-DWI for (early) response assessment during and early after neoadjuvant chemotherapy in comparison to CT with the aim to predict chemotherapy induced tumor load regression and subsequent operability

Secondary Outcome Measures

The prognostic value of DWI-determined imaging markers
The aim of this part of the study is the determination of prognostic DWI-determined imaging and response markers towards patients disease free survival and overall survival.

Full Information

First Posted
November 2, 2011
Last Updated
July 1, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
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1. Study Identification

Unique Protocol Identification Number
NCT01657747
Brief Title
Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer
Acronym
S53580
Official Title
Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to assess whole body diffusion weighted imaging (WB-DWI) as a non-invasive method for accurate staging of patient suspected having ovarian cancer early treatment assessment detecting tumor recurrence
Detailed Description
Staging --- (PET-)CT is used nowadays to provide imaging information about the disease burden of ovarian cancer patients and a diagnostic staging laparoscopy under general anesthesia is often necessary to allow correct and accurate staging. The applicant propose an "all-in-one" imaging modality providing high quality thoracic-abdominal images without using ionizing radiation and/or radioactive material. This allows accurate assessment of operability in a minimally invasive manner. Early treatment assessment --- Although response to the first administration of chemotherapy is quite reasonable, most patients show tumor recurrence and achieve increasingly poorer response rates to second- or third-line regimes. Therefore it is of major concern that a individualized prediction of chemosensitivity can be performed avoiding unnecessary toxicity from inefficient chemotherapeutic agents. A promising perspective is that the predictive data to be generated might prove to be sufficiently powerful to predict chemosensitivity early in the course of the treatment, facilitating a timely change of treatment in nonresponders. This could avoid unnecessary toxicity for patients, improving quality of life and moreover implicate considerable savings for the healthcare sector. Identifying tumor recurrence --- Identifying tumor recurrence at an early stage could translate into reduction of unnecessary biopsies, cost savings and reduced morbidity associated with the biopsy procedure. But the most important issue is that early diagnosis can be life saving with respect to tumor recurrence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Carcinoma
Keywords
Ovarian carcinoma, Staging, Early treatment follow-up, Identifying tumor recurrence, Whole body diffusion-weighted MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
350 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Not applicable (imaging study)
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Whole body diffusion-weighted MRI
Other Intervention Name(s)
Dotarem, Buscopan
Intervention Description
MRI is a technique based on magnetic fields and does not require the use of ionizing radiation. Although there are no known side effects associated with MRI, a few precautions should be taken because of the 3T magnetic field. This implicates that all metal and magnetized objects must be removed from the patient before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductors/prostheses are for this reason not eligible for the study. During the whole body MRI examination, an intravenous contrast agent will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine. During the whole body MRI examinations, a bowel relaxing injection (Buscopan) is also needed to reduce movement of the intestines.
Primary Outcome Measure Information:
Title
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
Description
Validation of interpretation criteria of WB-DWI for staging and thresholding for treatment assessment in pilot study
Time Frame
Nov 2011 - Sep 2012 (up to 1 year)
Title
WB-DWI for tumor characterization and staging at primary diagnosis
Description
The aim of this part of the study is to prospectively evaluate WB-DWI for tumor characterization and staging at primary diagnosis in comparison to CT and combined CT/diagnostic laparoscopy with the aim to assess patient operability.
Time Frame
Nov 2011 - Nov 2015 (expected) (up to 4 years)
Title
WB-DWI for response assessment during and early after neoadjuvant chemotherapy
Description
The aim of this part of the study is to prospectively evaluate WB-DWI for (early) response assessment during and early after neoadjuvant chemotherapy in comparison to CT with the aim to predict chemotherapy induced tumor load regression and subsequent operability
Time Frame
Nov 2011 - Nov 2015 (expected) (up to 4 years)
Secondary Outcome Measure Information:
Title
The prognostic value of DWI-determined imaging markers
Description
The aim of this part of the study is the determination of prognostic DWI-determined imaging and response markers towards patients disease free survival and overall survival.
Time Frame
Nov 2013 - Nov 2015 (expected) (up to 2 years)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: STAGING: patients with suspected ovarian carcinoma EARLY TREATMENT ASSESSMENT: patients with FIGO stage IIIc or IV ovarian carcinoma who will undergo neoadjuvant chemotherapy IDENTIFYING TUMOR RECURRENCE: patients with a medical history of ovarian carcinoma with suspicion of recurrent ovarian cancer after a disease-free-interval of at least 6 months Exclusion Criteria: patients with known contra-indications for MRI (cardiac pacemakers, cochlear implants, claustrophobic patients)will be excluded from this study. patients with contra-indications to gadolinium-based contrast agents (including patients with a known restricted renal function; GFR < 30 mL/min)and/or Buscopan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Vandecaveye, MD, PhD
Organizational Affiliation
UZ Leuven
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals UZ Leuven, Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium

12. IPD Sharing Statement

Learn more about this trial

Whole-body Diffusion MRI for Staging, Response Prediction and Detecting Tumor Recurrence in Patients With Ovarian Cancer

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