- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01246726
Multiple Oncological Serial Scans Study (MOSS)
The Tumour Bed as Target for Breast Irradiation Following Breast Conserving Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Bristol, United Kingdom, BS2 8ED
- University Hospitals Bristol NHS Foundation Trust
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
All female patients who, after breast conserving surgery, are to undergo whole breast irradiation with or without a boost. Ten patients will be for planned radiotherapy following both breast conservation surgery and chemotherapy and ten will be for planned radiotherapy following breast conservation surgery alone aged between 18 and 80years.
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Exclusion Criteria:
Mastectomy T3 or T4 and N3 cases Patients who have not undergone surgery Severely claustrophobic patients Patients unable to lie flat Patients with any contraindications to MRI
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Study Plan
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
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Within 3 months of radiotherapy completion
|
Collaborators and Investigators
Investigators
- Principal Investigator: Amit K Bahl, MD,MRCP,FRCR, University Hospitals Bristol and Weston NHS Foundation Trust
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- ON/2009/3235
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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