Multiple Oncological Serial Scans Study

Not Applicable

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT01246726
• Lead Sponsor: University Hospitals Bristol and Weston NHS Foundation Trust

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2010-03-31
• Study Start: 2010-11
• Study First Submitted QC: 2010-11-22
• Study First Posted: 2010-11-23
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-14
• Last Update Posted: 2016-11-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 9

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.

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Maximal dimensions of post operative complex will be obtained using the British Colombia Cancer Agency Seroma Clarity score scale.	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.

Trial Locations

Locations (1)

University Hospitals Bristol NHS Foundation trust; 🇬🇧 Bristol, United Kingdom