Diffusion-weighted Imaging Study in Cancer of the Ovary (DISCOVAR)

January 22, 2020 updated by: Nandita deSouza, Institute of Cancer Research, United Kingdom

Assessing Treatment Response of Peritoneal Metastases in Ovarian Cancer Using Diffusion Weighted Magnetic Resonance Imaging.

This project seeks to develop a quantitative imaging biomarker for evaluating and monitoring treatment response in ovarian cancer metastases and assess its potential in monitoring treatment response. This will involve standardising DW-MRI for the abdomen and pelvis across multiple centres and platforms, assessing reproducibility of the measurement in patients planned for neoadjuvant chemotherapy and assessing its utility as an early response biomarker in patients with platinum-sensitive relapse due to receive therapy with carboplatin. Scanning measurements will be correlated with histopathological markers in tumour samples in order to link the biomarker with response mechanisms.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

134

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, W6 8RF
        • Imperial College Healthcare NHS Trust
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
        • Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
    • Gateshead
      • Newcastle, Gateshead, United Kingdom, NE9 6SX
        • Queen Elizabeth Hospital
    • Middlesex
      • Northwood, Middlesex, United Kingdom, HA6 2RN
        • Mount Vernon Cancer Centre
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
    • Wales
      • Swansea, Wales, United Kingdom, SA2 8QA
        • Singleton Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with primary or relapsed ovarian cancer

Description

Inclusion Criteria:

  • Histologically confirmed ovarian, primary peritoneal or fallopian tube cancer stage III or IV
  • Scheduled to receive neoadjuvant chemotherapy (carboplatin/cisplatin)with planned debulking surgery.

Exclusion Criteria:

  • Life expectancy of less than 6 months
  • MRI contraindications
  • Low grade or heavily calcified disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Biological validation cohort 1
Response assessment cohort 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of a Quantitative Imaging Biomarker for Evaluating Ovarian Cancer Metastases and Assessment of its Potential in Monitoring Treatment Response.
Time Frame: 4.0 years
Diffusion-weighted magnetic resonance imaging (DW-MRI) for visualising peritoneal metastases will be developed.Reproducibility will be assessed in a multi-centre setting across multiple vendor platforms and field strengths by comparing 2 baseline scans per person and plotting absolute difference in ADC against mean of the 2 measurements.Biological validation will be achieved by correlating scan data (ADC change) following chemotherapy with histology of the tumour(amount of cell death) at surgery.
4.0 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Collaborators

Royal Marsden NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Cancer Research UK
East and North Hertfordshire NHS Trust
Imperial College Healthcare NHS Trust
Northumbria Healthcare NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2012

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

October 13, 2018

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

January 4, 2012

First Posted (ESTIMATE)

January 9, 2012

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 22, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11/LO/1598 CCR3694
  • C1353/A12762 (OTHER_GRANT: Cancer Research UK)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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