Multiple Oncological Serial Scans Study (MOSS)
Recruitment status was Recruiting
This is a pilot study comparing the appearance and volume of the post surgical region in the intact breast, as determined by 3 modalities: computed Xray tomography (CT), 3 Dimensional ultrasound (USS), Magnetic resonance imaging (MRI) after breast conserving surgery and during whole breast irradiation.
Procedure: CT SCAN
Procedure: MRI scan
Procedure: 3D Ultrasound scan
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||The Tumour Bed as Target for Breast Irradiation Following Breast Conserving Surgery|
- Maximal dimensions of post operative complex will be obtained using the British Colombia Cancer Agency Seroma Clarity score scale. [ Time Frame: Within 3 months of radiotherapy completion ] [ Designated as safety issue: No ]Each modality of investigation i.e. CT, MRI +USS will be evaluated using the Seroma clarity score scale to determine the most useful investigational tool.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||May 2012|
|Estimated Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Procedure: CT SCAN
Consenting patients who have undergone breast conserving surgery and who are planned to receive radiotherapy will have their first MRI and CT scan within 2 weeks of treatment planning. This will be followed by 3 weeks radiotherapy treatment. 3D ultrasound scans will be performed in the first 2 weeks before radiotherapy, during the 2nd and 3rd weeks of radiotherapy and in the 2 weeks following radiotherapy.Following the radiotherapy patients will undergo both CT and MRI scans within 2 weeks of treatment completion.The whole process should take approximately 10 weeks.In this study the CT scans, MRI scan + USS are above standard care and are the additional interventions in this study group.
|Contact: Amit K Bahl, MD,MRCP,FRCRfirstname.lastname@example.org|
|Contact: Sylvia Pearsonemail@example.com|
|University Hospitals Bristol NHS Foundation trust||Recruiting|
|Bristol, United Kingdom, BS2 8ED|
|Contact: Amit K Bahl, MD 01173423213 firstname.lastname@example.org|
|Contact: Sylvia Pearson 01173424263 email@example.com|
|Principal Investigator:||Amit K Bahl, MD,MRCP,FRCR||University Hospitals Bristol NHS Foundation Trust|