Multiple Oncological Serial Scans Study

NCT01246726 | Terminated

• 1 other identifier: ON/2009/3235
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

cancer, breast, radiotherapy, boost

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

CT SCAN PROCEDURE

Prior to radiotherapy + after radiotherapy completion

MRI scan PROCEDURE

Prior to radiotherapy + after completion of radiotherapy

3D Ultrasound scan PROCEDURE

Prior to radiotherapy + after completion of radiotherapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Bristol and Weston NHS Foundation Trust: lead
• Bosum Buddies: collaborator
• Friends of the Bristol Haematology and Oncology Centre: collaborator

Study Sites (1)

University Hospitals Bristol NHS Foundation trust

Bristol, Bristol, BS2 8ED, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Amit K Bahl, MD,MRCP,FRCR

  University Hospitals Bristol and Weston NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: November 23, 2010
• Study Start: November 1, 2010
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

GB (1)