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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2016 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
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: June 13, 2016
Last verified: June 2016
  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 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 ] [ 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.


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

Estimated Enrollment: 120
Study Start Date: August 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Biological validation cohort 1
Response assessment cohort 2

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01505829

Contacts
Contact: Nandita deSouza, Professor 0208 661 3289 nandita.desouza@icr.ac.uk
Contact: Katherine May, BSc 0208 642 6011 ext 4109 katherine.may@rmh.nhs.uk

Locations
United Kingdom
Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Contact: Sue Freeman, Dr    01223 216911    sue.freeman@addenbrookes.nhs.uk   
Contact: Wendy Phillips       wendyphillips@addenbrookes.nhs.uk   
Principal Investigator: Sue Freeman, Dr         
Queen Elizabeth Hospital Completed
Newcastle, Gateshead, United Kingdom, NE9 6SX
The Institute of Cancer Research and Royal Marsden NHS Foundation Trust Recruiting
Sutton, Surrey, United Kingdom, SM2 5PT
Contact: Nandita deSouza, Professor    0208 661 3289    nandita.desouza@icr.ac.uk   
Contact: Katherine May, BSc    0208 642 6011 ext 4109    katherine.may@rmh.nhs.uk   
Principal Investigator: Nandita deSouza, Professor         
Singleton Hospital Recruiting
Swansea, Wales, United Kingdom, SA2 8QA
Contact: Kerryn Lutchman-Singh, Dr       kerryn.lutchman-singh@wales.nhs.uk   
Contact: Dawn Withers       dawn.withers@wales.nhs.uk   
Principal Investigator: Kerryn Lutchman-Singh, Consultant         
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom, W6 8RF
Contact: Hani Gabra, Professor       h.gabra@imperial.ac.uk   
Contact: Maria Martinez    0208 3833089    m.martinez@imperial.ac.uk   
Principal Investigator: Hani Gabra, Professor         
Mount Vernon Cancer Centre Recruiting
Northwood, Middlesex, United Kingdom, HA6 2RN
Contact: Marcia Hall, MBBS PhD FRCP       marcia.hall@nhs.net   
Principal Investigator: Marcia Hall, MBBS PhD FRCP         
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 
Study First Received: November 18, 2011
Last Updated: June 13, 2016
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on September 29, 2016