Breast CancerBreast MRINCT01300585
MRI Evaluation of the Breast Areolar Margin and Paryenchyma
A study testing MRI in people with Breast Cancer, run by Piedmont Healthcare at 1 site in United States.
Trial summary
The purpose of this study is to test a new method of defining patterns of how breast glands are or are not attached to the overlying skin. All patients will have markers placed on both breasts and will undergo an MRI. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2011to May 2014
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have one of the following indications for MRI study of the breast - screening for high risk without evidence of disease, have existing breast cancer with need for evaluation of extent of disease or to rule out additional occult cancer, or to have an equivocal mammogram or ultrasound requiring additional information from MRI.
- No prior breast surgery including prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants.
- Capable of fitting into the MRI machine.
- Permission to contact and consent the patient to participate from the investigator(s)
- Provide written informed consent and Authorization for Use/Disclosure of PHI
Who cannot join
- Have a contraindication to MRI study.
- Prior breast surgery - this includes: prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants [Patients may have undergone prior percutaneous (needle) biopsy or fine needle aspiration]
- Inability to fit into the MRI machine.
- Psychological factors that may interfere with successful completion of the study
- Refusal to provide written informed consent and/or Authorization for Use/Disclosure of PHI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MRI Evaluation to Assess the Relationship Between the Areolar Margin and Underlying Breast Paryenchyma Attachments to the Dermis
The purpose of this study is to test a new method of defining patterns of how breast glands are or are not attached to the overlying skin. All patients will have markers placed on both breasts and will undergo an MRI. MRI results will be examined to identify the pattern of breast gland attachment to the overlying skin. This will help identify patients which may benefit from areolar sparing and/or nipple sparing technique and which patients should be treated by standard mastectomy.
- Conditions
- Breast Cancer
- Being tested
- MRI
- Keywords
- Breast, Cancer
- 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.
MRIOther
Patients who qualify for the study and consent to be included will undergo placement of areola and nipple markers that will be held in place with tape for the duration of the ordered MRI study. The markers consist of latex-free plastic tubing filled with vegetable based hydrogenated oil that is solid at room temperature. This creates a fat density marker that will define the areola but does not interfere with or create artifact onto the underlying tissue. The marker can be placed by the investigator or available MRI technician instructed in marker placement. The patient will then undergo the MRI. The patients participation in the study will end with the MRI.
| Study group | Role | What they receive |
|---|---|---|
| MRI | Other | All patients on study will undergo an MRI of the breast(s). Receives: Other: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patterns of Breast Gland Attachment
Identify the various patterns of breast gland attachment to the overlying skin.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startFeb 2011
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Lack of patient population
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Piedmont Healthcare
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Richardson, MD, Principal investigator, Piedmont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300585
- Sponsor's protocol ID
- Breast MRI
- Acronym
- Breast MRI
- Status last verified
- May 2014
- First submitted
- 17 Feb 2011
- Last updated
- 5 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Evaluation to Assess the Relationship Between the Areolar Margin and Underlying Breast Paryenchyma Attachments to the Dermis
- ClinicalTrials.gov ID
- NCT01300585
- Acronym / sponsor ID
- Breast MRI / Breast MRI
- Conditions
- Breast Cancer
- Keywords
- Breast, Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patient population
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Piedmont HealthcareUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 21 Feb 2011 (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.
The purpose of this study is to test a new method of defining patterns of how breast glands are or are not attached to the overlying skin. All patients will have markers placed on both breasts and will undergo an MRI. MRI results will be examined to identify the pattern of breast gland attachment to the overlying skin. This will help identify patients which may benefit from areolar sparing and/or nipple sparing technique and which patients should be treated by standard mastectomy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI | Other | Other: MRIAll patients on study will undergo an MRI of the breast(s). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have one of the following indications for MRI study of the breast - screening for high risk without evidence of disease, have existing breast cancer with need for evaluation of extent of disease or to rule out additional occult cancer, or to have an equivocal mammogram or ultrasound requiring additional information from MRI.
- No prior breast surgery including prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants.
- Capable of fitting into the MRI machine.
- Permission to contact and consent the patient to participate from the investigator(s)
- Provide written informed consent and Authorization for Use/Disclosure of PHI
Key exclusion criteria (5 listed)
- Have a contraindication to MRI study.
- Prior breast surgery - this includes: prior excisional biopsies for disease performed with surgical technique, breast augmentation, reduction mammoplasty or breast lift with or without implants [Patients may have undergone prior percutaneous (needle) biopsy or fine needle aspiration]
- Inability to fit into the MRI machine.
- Psychological factors that may interfere with successful completion of the study
- Refusal to provide written informed consent and/or Authorization for Use/Disclosure of PHI
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 |
|---|---|---|
| MRIPatients who qualify for the study and consent to be included will undergo placement of areola and nipple markers that will be held in place with tape for the duration of the ordered MRI study. The markers consist of latex-free plastic tubing filled with vegetable based hydrogenated oil that is solid at room temperature. This creates a fat density marker that will define the areola but does not interfere with or create artifact onto the underlying tissue. The marker can be placed by the investigator or available MRI technician instructed in marker placement. The patient will then undergo the MRI. The patients participation in the study will end with the MRI. | Other | MRI |
Primary outcome
Patterns of Breast Gland Attachment
Time frame: 6 months
Identify the various patterns of breast gland attachment to the overlying skin.
Results and safety
The study was stopped early (reason given: Lack of patient population). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
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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.
Heather Richardson, MD principal investigator
Piedmont Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Breast Cancer, run by Piedmont Healthcare at 1 site in United States.
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 5 inclusion and 5 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 5 May 2014. 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 States. 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: Lack of patient population). 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?
Patterns of Breast Gland Attachment (time frame: 6 months). 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 5 May 2014.