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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01505829
First Posted: January 9, 2012
Last Update Posted: September 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cancer Research UK
Royal Marsden NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Imperial College Healthcare NHS Trust
Northumbria Healthcare NHS Foundation Trust
East and North Hertfordshire NHS Trust
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom
  Purpose
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.

Condition
Ovarian Cancer Peritoneal Metastases

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessing Treatment Response of Peritoneal Metastases in Ovarian Cancer Using Diffusion Weighted Magnetic Resonance Imaging.

Resource links provided by NLM:


Further study details as provided by NdeSouza, Institute of Cancer Research, United Kingdom:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
Tumour samples taken at surgery for histological analysis

Enrollment: 134
Actual Study Start Date: August 2012
Estimated Study Completion Date: December 2018
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Biological validation cohort 1
Response assessment cohort 2

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with primary or relapsed ovarian cancer
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01505829


Locations
United Kingdom
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Queen Elizabeth Hospital
Newcastle, Gateshead, United Kingdom, NE9 6SX
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Singleton Hospital
Swansea, Wales, United Kingdom, SA2 8QA
Imperial College Healthcare NHS Trust
London, United Kingdom, W6 8RF
Mount Vernon Cancer Centre
Northwood, Middlesex, United Kingdom, HA6 2RN
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
Cancer Research UK
Royal Marsden NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
Imperial College Healthcare NHS Trust
Northumbria Healthcare NHS Foundation Trust
East and North Hertfordshire NHS Trust
Investigators
Principal Investigator: Nandita deSouza, Professor ICR
  More Information

Responsible Party: NdeSouza, Clinical Professor, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT01505829     History of Changes
Other Study ID Numbers: 11/LO/1598 CCR3694
C1353/A12762 ( Other Grant/Funding Number: Cancer Research UK )
First Submitted: November 18, 2011
First Posted: January 9, 2012
Last Update Posted: September 15, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Neoplasm Metastasis
Ovarian Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders