Diffusion-weighted Imaging Study in Cancer of the Ovary (DISCOVAR)
This study is currently recruiting participants.
Verified January 2013 by Institute of Cancer Research, United Kingdom
Sponsor:
Institute of Cancer Research, United Kingdom
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
Information provided by (Responsible Party):
NdeSouza, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier:
NCT01505829
First received: November 18, 2011
Last updated: January 30, 2013
Last verified: January 2013
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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 2015 |
| Estimated Primary Completion Date: | December 2014 (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 |
| 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
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 8642 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 | |
| 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 661 3340 katherine.may@rmh.nhs.uk | |
| Imperial College Healthcare NHS Trust | Recruiting |
| London, United Kingdom, W6 8RF | |
| Contact: Andrea Rockall, Professor a.rockall@imperial.ac.uk | |
| Contact: Maria Martinez 0208 3833089 m.martinez@imperial.ac.uk | |
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
Investigators
| Principal Investigator: | Nandita deSouza, Professor | ICR |
More Information
No publications provided
| 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: | January 30, 2013 |
| 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 June 18, 2013