Breast CancerMOSSNCT01246726
Multiple Oncological Serial Scans Study
A study testing CT SCAN, MRI scan and 3D Ultrasound scan in people with Breast Cancer, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- CT SCAN, MRI scan and 3D Ultrasound scan
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Nov 2010to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Bristol NHS Foundation trust
Bristol, Bristol, BS2 8ED
About this study
Official title: The Tumour Bed as Target for Breast Irradiation Following Breast Conserving Surgery
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- CT SCAN, MRI scan, 3D Ultrasound scan
- Keywords
- cancer, breast, radiotherapy, boost
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT SCANProcedure or surgery
Prior to radiotherapy + after radiotherapy completion
MRI scanProcedure or surgery
Prior to radiotherapy + after completion of radiotherapy
3D Ultrasound scanProcedure or surgery
Prior to radiotherapy + after completion of radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months of radiotherapy completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: MRI scanner de-commissioned and there was no suitable alternative.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Bosum Buddies, Friends of the Bristol Haematology and Oncology Centre
- Responsible party
- Sponsor
- Investigators
- Amit K Bahl, MD,MRCP,FRCR, Principal investigator, University Hospitals Bristol and Weston NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01246726
- Sponsor's protocol ID
- ON/2009/3235
- Acronym
- MOSS
- Status last verified
- Nov 2016
- First submitted
- 31 Mar 2010
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tumour Bed as Target for Breast Irradiation Following Breast Conserving Surgery
- ClinicalTrials.gov ID
- NCT01246726
- Acronym / sponsor ID
- MOSS / ON/2009/3235
- Conditions
- Breast Cancer
- Keywords
- cancer, breast, radiotherapy, boost
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: MRI scanner de-commissioned and there was no suitable alternative.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospitals Bristol and Weston NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Bosum Buddies, Friends of the Bristol Haematology and Oncology Centre
- Study start
- Nov 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 23 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
- -
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT SCANPrior to radiotherapy + after radiotherapy completion | Procedure or surgery | – |
| MRI scanPrior to radiotherapy + after completion of radiotherapy | Procedure or surgery | – |
| 3D Ultrasound scanPrior to radiotherapy + after completion of radiotherapy | Procedure or surgery | – |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: MRI scanner de-commissioned and there was no suitable alternative.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amit K Bahl, MD,MRCP,FRCR principal investigator
University Hospitals Bristol and Weston NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT SCAN, MRI scan and 3D Ultrasound scan in people with Breast Cancer, run by University Hospitals Bristol and Weston NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: MRI scanner de-commissioned and there was no suitable alternative.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2016.