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DISCOVAR: Diffusion-weighted Imaging Study in Cancer of the Ovary

Sponsor
Institute of Cancer Research, United Kingdom (Other)
Overall Status
Completed
CT.gov ID
NCT01505829
Collaborator
Cancer Research UK (Other), Royal Marsden NHS Foundation Trust (Other), Cambridge University Hospitals NHS Foundation Trust (Other), Imperial College Healthcare NHS Trust (Other), Northumbria Healthcare NHS Foundation Trust (Other), East and North Hertfordshire NHS Trust (Other)
134
Enrollment
6
Locations
74.4
Actual Duration (Months)
22.3
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    134 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Assessing Treatment Response of Peritoneal Metastases in Ovarian Cancer Using Diffusion Weighted Magnetic Resonance Imaging.
    Actual Study Start Date :
    Aug 1, 2012
    Actual Primary Completion Date :
    Dec 1, 2016
    Actual Study Completion Date :
    Oct 13, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Biological validation cohort 1
    Response assessment cohort 2

    Outcome Measures

    Primary Outcome Measures

    1. Development of a Quantitative Imaging Biomarker for Evaluating Ovarian Cancer Metastases and Assessment of its Potential in Monitoring Treatment Response. [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

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

    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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nandita deSouza, Clinical Professor, Institute of Cancer Research, United Kingdom
    ClinicalTrials.gov Identifier:
    NCT01505829
    Other Study ID Numbers:
    • 11/LO/1598 CCR3694
    • C1353/A12762
    First Posted:
    Jan 9, 2012
    Last Update Posted:
    Jan 23, 2020
    Last Verified:
    Jan 1, 2020
    Additional relevant MeSH terms:
    Neoplasm Metastasis
    Ovarian Neoplasms
    Carcinoma, Ovarian Epithelial

    Study Results

    No Results Posted as of Jan 23, 2020