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


N/A
18 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.


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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Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Within 3 months of radiotherapy completion

Safety Issue:

No

Principal Investigator

Amit K Bahl, MD,MRCP,FRCR

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Hospitals Bristol NHS Foundation Trust

Authority:

United Kingdom: Research Ethics Committee

Study ID:

ON/2009/3235

NCT ID:

NCT01246726

Start Date:

November 2010

Completion Date:

May 2012

Related Keywords:

  • Breast Cancer
  • cancer, breast, radiotherapy, boost
  • Breast Neoplasms

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