Multiple Oncological Serial Scans Study (MOSS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by United Bristol Healthcare NHS Trust.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Bosum Buddies
Friends of the Bristol Haematology and Oncology Centre
Information provided by (Responsible Party):
United Bristol Healthcare NHS Trust
ClinicalTrials.gov Identifier:
NCT01246726
First received: March 31, 2010
Last updated: February 3, 2012
Last verified: October 2010
  Purpose

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.


Condition Intervention
Breast Cancer
Procedure: CT SCAN
Procedure: MRI scan
Procedure: 3D Ultrasound scan

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by United Bristol Healthcare NHS Trust:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 20
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)
Intervention Details:
    Procedure: CT SCAN
    Prior to radiotherapy + after radiotherapy completion
    Procedure: MRI scan
    Prior to radiotherapy + after completion of radiotherapy
    Procedure: 3D Ultrasound scan
    Prior to radiotherapy + after completion of radiotherapy
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01246726

Contacts
Contact: Amit K Bahl, MD,MRCP,FRCR 01173423213 amit.bahl@uhbristol.nhs.uk
Contact: Sylvia Pearson 01173424263 sylvia.pearson@uhbristol.nhs.uk

Locations
United Kingdom
University Hospitals Bristol NHS Foundation trust Recruiting
Bristol, United Kingdom, BS2 8ED
Contact: Amit K Bahl, MD    01173423213    amit.bahl@uhbristol.nhs.uk   
Contact: Sylvia Pearson    01173424263    sylvia.pearson@uhbristol.nhs.uk   
Sponsors and Collaborators
United Bristol Healthcare NHS Trust
Bosum Buddies
Friends of the Bristol Haematology and Oncology Centre
Investigators
Principal Investigator: Amit K Bahl, MD,MRCP,FRCR University Hospitals Bristol NHS Foundation Trust
  More Information

No publications provided

Responsible Party: United Bristol Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT01246726     History of Changes
Other Study ID Numbers: ON/2009/3235
Study First Received: March 31, 2010
Last Updated: February 3, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by United Bristol Healthcare NHS Trust:
cancer, breast, radiotherapy, boost

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 16, 2014