ClinicalTrials.gov
ClinicalTrials.gov Menu

Multiple Oncological Serial Scans Study (MOSS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01246726
Recruitment Status : Terminated (MRI scanner de-commissioned and there was no suitable alternative.)
First Posted : November 23, 2010
Last Update Posted : November 15, 2016
Sponsor:
Collaborators:
Bosum Buddies
Friends of the Bristol Haematology and Oncology Centre
Information provided by (Responsible Party):
University Hospitals Bristol 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: CT SCAN Procedure: MRI scan Procedure: 3D Ultrasound scan Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: The Tumour Bed as Target for Breast Irradiation Following Breast Conserving Surgery
Study Start Date : November 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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


Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes 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.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01246726


Locations
United Kingdom
University Hospitals Bristol NHS Foundation trust
Bristol, United Kingdom, BS2 8ED
Sponsors and Collaborators
University Hospitals Bristol NHS Foundation 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

Responsible Party: University Hospitals Bristol NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01246726     History of Changes
Other Study ID Numbers: ON/2009/3235
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by University Hospitals Bristol NHS Foundation Trust:
cancer, breast, radiotherapy, boost