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Multiple Oncological Serial Scans Study

NCT ID: NCT01246726

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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.

Conditions

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Breast Cancer

Keywords

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cancer, breast, radiotherapy, boost

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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CT SCAN

Prior to radiotherapy + after radiotherapy completion

Intervention Type PROCEDURE

MRI scan

Prior to radiotherapy + after completion of radiotherapy

Intervention Type PROCEDURE

3D Ultrasound scan

Prior to radiotherapy + after completion of radiotherapy

Intervention Type PROCEDURE

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bosum Buddies

UNKNOWN

Sponsor Role collaborator

Friends of the Bristol Haematology and Oncology Centre

UNKNOWN

Sponsor Role collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amit K Bahl, MD,MRCP,FRCR

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Bristol and Weston NHS Foundation Trust

Locations

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University Hospitals Bristol NHS Foundation trust

Bristol, Bristol, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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ON/2009/3235

Identifier Type: -

Identifier Source: org_study_id