Diffusion-weighted Imaging Study in Cancer of the Ovary

Ovarian Cancer Clinical Trial

— DISCOVAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01505829
• Other study ID #: 11/LO/1598 CCR3694
• Secondary ID: C1353/A12762
• Status: Completed
• Start date: August 2012
• Est. completion date: October 13, 2018

Study information

• Verified date: January 2020
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: October 13, 2018
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Neoplasm Metastasis
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Metastases

Locations

Country	Name	City	State
United Kingdom	Addenbrookes Hospital, Cambridge University Hospitals NHS Foundation Trust	Cambridge	Cambridgeshire
United Kingdom	Imperial College Healthcare NHS Trust	London
United Kingdom	Queen Elizabeth Hospital	Newcastle	Gateshead
United Kingdom	Mount Vernon Cancer Centre	Northwood	Middlesex
United Kingdom	The Institute of Cancer Research and Royal Marsden NHS Foundation Trust	Sutton	Surrey
United Kingdom	Singleton Hospital	Swansea	Wales

Sponsors (7)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom	Cambridge University Hospitals NHS Foundation Trust, Cancer Research UK, East and North Hertfordshire NHS Trust, Imperial College Healthcare NHS Trust, Northumbria Healthcare NHS Foundation Trust, Royal Marsden NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of a Quantitative Imaging Biomarker for Evaluating Ovarian Cancer Metastases and Assessment of its Potential in Monitoring Treatment Response.	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.	4.0 years