Diffusion-weighted Imaging Study in Cancer of the Ovary

Completed

• Conditions: Ovarian Cancer; Peritoneal Metastases

• Registration Number: NCT01505829
• Lead Sponsor: Institute of Cancer Research, United Kingdom

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-11-18
• Study First Submitted QC: 2012-01-04
• Study First Posted: 2012-01-09
• Study Start: 2012-08
• Primary Completion: 2016-12
• Study Completion: 2018-10-13
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-22
• Last Update Posted: 2020-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 134

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (6)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom

Queen Elizabeth Hospital; 🇬🇧 Newcastle, Gateshead, United Kingdom

Singleton Hospital; 🇬🇧 Swansea, Wales, United Kingdom

The Institute of Cancer Research and Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom

Mount Vernon Cancer Centre; 🇬🇧 Northwood, Middlesex, United Kingdom