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

This study is currently recruiting participants.
Verified June 2013 by Institute of Cancer Research, United Kingdom
Sponsor:
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
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01505829
First received: November 18, 2011
Last updated: June 20, 2013
Last verified: June 2013

November 18, 2011
June 20, 2013
August 2012
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
This will involve developing diffusion-weighted magnetic resonance imaging (DW-MRI) for visualising peritoneal metastases and demonstrating its reproducibility in a multi-centre setting across multiple vendor platforms and field strengths. Biological validation will be achieved by correlating scan data following chemotherapy with histology of the tumour(amount of cell death) at subsequent surgery.
Complete list of historical versions of study NCT01505829 on ClinicalTrials.gov Archive Site
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Diffusion-weighted Imaging Study in Cancer of the Ovary
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Tumour samples taken at surgery for histological analysis

Probability Sample

Patients with primary or relapsed ovarian cancer

  • Ovarian Cancer
  • Peritoneal Metastases
Not Provided
  • Biological validation cohort 1
  • Response assessment cohort 2
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 80 Years
Yes
Contact: Nandita deSouza, Professor 0208 661 3289 nandita.desouza@icr.ac.uk
Contact: Katherine May, BSc 0208 8642 6011 ext 4109 katherine.may@rmh.nhs.uk
United Kingdom
 
NCT01505829
11/LO/1598 CCR3694, C1353/A12762
No
NdeSouza, Institute of Cancer Research, United Kingdom
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
Principal Investigator: Nandita deSouza, Professor ICR
Institute of Cancer Research, United Kingdom
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP