Breast CancerNCT02956473
Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy
A study testing Supine MRI, Neoadjuvant Therapy (NAT) and Ultrasound in people with Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying… 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?
- Supine MRI, Neoadjuvant Therapy (NAT) and Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Nov 2016to Aug 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Participants must be female
- Participants must have a pre-operative standard mammogram with or without ultrasound.
- Participants must have biopsy confirmed and clinical stage I, stage II, or stage III non-inflammatory breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at (BWH, BWFH)
- Patient must meet standard MRI guidelines and be able and willing to undergo MRI
- Participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following NAT (this takes into account tumor to breast size ratio appropriate for BCT, and the ability to undergo standard radiation therapy post-operatively).
- Study participants will be restricted to those aged ≥18 years old. This age group is selected because it encompasses the majority of women likely to receive neoadjuvant therapy
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Participants with a known BRCA 1 or 2 mutation.
- Participants with a known Li-Fraumeni or Cowden's Disease.
- Participants with prior mantle radiation.
- Participants with inflammatory breast cancer or multi-centric disease
- Participants who are pregnant.
- Participants who are already enrolled in a conflicting investigational trial
Show all 11Show fewer
- Participants with known active collagen vascular disease.
- Participants with prior history of ipsilateral breast carcinoma treated with BCS and radiation therapy.
- Patients who have biopsy confirmed multi-centric disease.
- Participants who are unable to undergo MRI because of documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure
- Participants who exceed the weight limit for the operative surgical table, 350 lbs or who will not fit into the 60 cm diameter bore of the MRI scanner.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
This research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).
Read the detailed description
The procedure involved is called a supine breast magnetic resonance imaging (MRI).In this study, the investigators are evaluating the value of supine MRI in surgical decision making for women with breast cancer either undergoing upfront surgery or for those anticipating surgery after receiving neoadjuvant therapy.
The purpose of this study is to assess the value of supine breast MRI as a new imaging method to assist in surgical treatment planning. It is possible that the use of supine breast MRI will help your doctor see the size and location of tumors more accurately
- Conditions
- Breast Cancer
- Being tested
- Supine MRI, Neoadjuvant Therapy (NAT), Ultrasound, Mammography, Standard of Care
- Keywords
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supine MRIDevice
Neoadjuvant Therapy (NAT)Other
UltrasoundDevice
MammographyDevice
Standard of CareProcedure or surgery
Standard MRIDevice
| Study group | Role | What they receive |
|---|---|---|
| Supine MRI | Experimental | * Standard MRI will be performed
* Supine MRI will be performed
* Participant will receive mammography and ultrasound
* Breast Radiologist will take a brief survey.
* Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care
* Standard of care will be performed Receives: Device: Supine MRI; Other: Neoadjuvant Therapy (NAT); Device: Ultrasound; Device: Mammography; Procedure: Standard of Care; Device: Standard MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size
Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used.
Measured: time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)
Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size
Compared tumor size as reported by radiologist on the clinical report between Supine Breast MRI and The Pathologic Residual Tumor Size as reported by the pathologist on the final surgical pathology report..
Measured: time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days
Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions.
Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images
Measured: at time of MRI imaging
Secondary outcomes (1)
The Perceived Benefit Of Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing Breast-conserving Therapy (BCT) In Our Study Patient Population
Reported as the proportion of surgeons answering yes. Surgeon reported answers to surveys asking if the supine MRI helped in the performance of the surgical procedure.
Measured: after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2016 (estimated)
- Study start15 Nov 2016
- Primary completionAug 2022
- Study completionAug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tari King, MD, Dana-Farber Cancer Institute
- Investigators
- Tari King, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02956473
- Sponsor's protocol ID
- 16-277
- Status last verified
- Feb 2024
- First submitted
- 3 Nov 2016
- Last updated
- 12 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supine MRI in Breast Cancer Patients Undergoing Upfront Surgery or Receiving Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT02956473
- Acronym / sponsor ID
- 16-277
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 15 Nov 2016 (actual)
- Primary completion
- Aug 2022 (actual)
- Study completion
- Aug 2022 (actual)
- First posted
- 7 Nov 2016 (estimated)
- Results
- Posted 12 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study involves the use of a common breast imaging modality (magnetic resonance imaging, 'MRI') and is investigating its role in evaluating surgical decision making for breast cancer when it is performed with the patient in a new position (lying on one's back) as opposed to in the standard position (lying on one's stomach).
Detailed description
The procedure involved is called a supine breast magnetic resonance imaging (MRI).In this study, the investigators are evaluating the value of supine MRI in surgical decision making for women with breast cancer either undergoing upfront surgery or for those anticipating surgery after receiving neoadjuvant therapy.
The purpose of this study is to assess the value of supine breast MRI as a new imaging method to assist in surgical treatment planning. It is possible that the use of supine breast MRI will help your doctor see the size and location of tumors more accurately
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supine MRI | Experimental | Device: Supine MRI, Other: Neoadjuvant Therapy (NAT), Device: Ultrasound, Device: Mammography, Procedure: Standard of Care, Device: Standard MRI* Standard MRI will be performed * Supine MRI will be performed * Participant will receive mammography and ultrasound * Breast Radiologist will take a brief survey. * Patients will undergo upfront surgery or receive Neoadjuvant Therapy per standard of care * Standard of care will be performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants must be female
- Participants must have a pre-operative standard mammogram with or without ultrasound.
- Participants must have biopsy confirmed and clinical stage I, stage II, or stage III non-inflammatory breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at (BWH, BWFH)
- Patient must meet standard MRI guidelines and be able and willing to undergo MRI
- Participants must be candidates for definitive local therapy with breast conserving therapy or deemed as potential candidates following NAT (this takes into account tumor to breast size ratio appropriate for BCT, and the ability to undergo standard radiation therapy post-operatively).
Key exclusion criteria (11 listed)
- Participants with a known BRCA 1 or 2 mutation.
- Participants with a known Li-Fraumeni or Cowden's Disease.
- Participants with prior mantle radiation.
- Participants with inflammatory breast cancer or multi-centric disease
- Participants who are pregnant.
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 |
|---|---|---|
| Supine MRI | Device | Supine MRI |
| Neoadjuvant Therapy (NAT) | Other | Supine MRI |
| Ultrasound | Device | Supine MRI |
| Mammography | Device | Supine MRI |
| Standard of Care | Procedure or surgery | Supine MRI |
| Standard MRI | Device | Supine MRI |
Primary outcome
Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size
Time frame: time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)
Comparing tumor size as measured on prone MRI images with tumor size as measured on final pathology among pts undergoing upfront surgery and among pts undergoing neoadjuvant chemotherapy. In the neoadjuvant chemotherapy group the post-treatment MRI images were used.
Correlation Between Supine Breast MRI for Estimation Of Tumor Size and The Pathologic Tumor Size
Time frame: time between supine breast MRI imaging and surgery; median 25.5 days, range 11-40 days
Compared tumor size as reported by radiologist on the clinical report between Supine Breast MRI and The Pathologic Residual Tumor Size as reported by the pathologist on the final surgical pathology report..
Correlation of Breast Tumor Dimensions Between Prone and Supine Imaging Positions.
Time frame: at time of MRI imaging
Correlate maximal tumor Dimensions as measured by the radiologist between the Prone and Supine MRI Images
1 secondary outcome
The Perceived Benefit Of Supine MRI For Surgical Planning As Measured By The Collective Results Of A Survey Of Surgeons Performing Breast-conserving Therapy (BCT) In Our Study Patient Population
Time frame: after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Tari King, MD principal investigator
Brigham and Women's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine MRI, Neoadjuvant Therapy (NAT) and Ultrasound in people with Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites 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 7 inclusion and 11 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: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 12 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Correlation Between Prone Breast MRI for Estimation of Tumor Size and Final Pathology Tumor Size (time frame: time between MRI date (when prone imaging measurements were obtained) and surgery date; median 25.5 days (range 11-40days)). The study lists 3 primary outcomes in all. 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 12 Mar 2024.