Multiple Oncological Serial Scans Study

Breast Cancer Clinical Trial

— MOSS  

Official title:

The Tumour Bed as Target for Breast Irradiation Following Breast Conserving Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01246726
• Other study ID #: ON/2009/3235
• Status: Terminated
• Phase: N/A
• First received: March 31, 2010
• Last updated: November 14, 2016
• Start date: November 2010
• Est. completion date: March 2013

Study information

• Verified date: November 2016
• Source: University Hospitals Bristol NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• CT SCAN
Prior to radiotherapy + after radiotherapy completion
• MRI scan
Prior to radiotherapy + after completion of radiotherapy
• 3D Ultrasound scan
Prior to radiotherapy + after completion of radiotherapy

Locations

Country	Name	City	State
United Kingdom	University Hospitals Bristol NHS Foundation trust	Bristol

Sponsors (3)

Lead Sponsor	Collaborator
University Hospitals Bristol NHS Foundation Trust	Bosum Buddies, Friends of the Bristol Haematology and Oncology Centre

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximal dimensions of post operative complex will be obtained using the British Colombia Cancer Agency Seroma Clarity score scale.	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.	Within 3 months of radiotherapy completion	No