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

This study is ongoing, but not recruiting participants.
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
East and North Hertfordshire NHS Trust
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01505829
First received: November 18, 2011
Last updated: September 14, 2017
Last verified: September 2017
November 18, 2011
September 14, 2017
August 2012
December 2016   (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 ]
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 ]
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
Not Provided
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.
 
Active, not recruiting
134
December 2018
December 2016   (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
Sexes Eligible for Study: Female
18 Years to 80 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT01505829
11/LO/1598 CCR3694
C1353/A12762 ( Other Grant/Funding Number: Cancer Research UK )
No
Not Provided
Not Provided
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
  • East and North Hertfordshire NHS Trust
Principal Investigator: Nandita deSouza, Professor ICR
Institute of Cancer Research, United Kingdom
September 2017

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