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Clinical Trials/NCT01505829
NCT01505829
Completed
Not Applicable

Assessing Treatment Response of Peritoneal Metastases in Ovarian Cancer Using Diffusion Weighted Magnetic Resonance Imaging.

Institute of Cancer Research, United Kingdom6 sites in 1 country134 target enrollmentAugust 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
Institute of Cancer Research, United Kingdom
Enrollment
134
Locations
6
Primary Endpoint
Development of a Quantitative Imaging Biomarker for Evaluating Ovarian Cancer Metastases and Assessment of its Potential in Monitoring Treatment Response.
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
October 13, 2018
Last Updated
6 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Institute of Cancer Research, United Kingdom
Responsible Party
Principal Investigator
Principal Investigator

Nandita deSouza

Clinical Professor

Institute of Cancer Research, United Kingdom

Eligibility 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

Outcomes

Primary Outcomes

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.

Study Sites (6)

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