Breast CancerNCT01929395
A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery
A study testing Supine MRI in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This is a 2 Phase study. In the first phase of the study, patients with palpable invasive breast cancer underwent pre-operative supine MRI and optical scanning in the surgical position. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Supine MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Jul 2018
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than/equal to 18 years
- Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
- Patient desire to undergo breast surgery
- 3. Patients will have provided informed consent to participate, documented by their signature on the study consent form 4. The cancer enhances on breast MRI imaging.
- Age greater than/equal to 18 years
- Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
Show all 10Show fewer
- The tumor is visible and enhances on prone MRI and is >1 cm in greatest diameter.
- . Determination by the surgeon that the neoplasm is non-palpable.A patient with a palpable hematoma from core biopsy, but a non-palpable neoplasm, will be eligible for study
- Patient desire to undergo breast conserving surgery
- Patients will have provided informed consent to participate, documented by their signature on the study consent form.The process of informed consent will be documented in the medical record and a copy of the signed consent form will be given to the patient.
Who cannot join
- Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes
- Severe claustrophobia
- Contraindication to use of gadolinium based intravenous contrast, including life threatening allergy or compromised renal function (creatinine > 2.0)
- History of median sternotomy
- Pregnancy (Patient attestation that they are not pregnant will be acceptable, as per standard, as per standard policy for MRIs at DHMC).
- Multicentric breast cancer, defined as two or more tumors in different quadrants of the breast. An eligibility worksheet will be completed for each patient prior to enrollment and will be signed and dated by the surgeon investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
This is a 2 Phase study. In the first phase of the study, patients with palpable invasive breast cancer underwent pre-operative supine MRI and optical scanning in the surgical position. In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.
Read the detailed description
We propose to use a novel technique (optical scanning) to correlate the supine MRI image to the surgical position in the OR and then to confirm and extend the Japanese study described above. In the first phase of the study, 5-25 patients with palpable invasive breast cancer will undergo pre-operative supine MRI and optical scanning in the surgical position. The purpose of this phase will be ensure that the images created from the optical scanner-adjusted supine MRI images closely correspond to the location of the palpable tumors in these breasts. All patients will then have their tumor resected using the standard method of either palpation or image guided wire localization. The first phase has been completed.
In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.
Our secondary objectives will be to determine:
- whether there are differences between the two groups in the volume of breast tissue removed.
- whether diagnostic information obtained from a supine MRI is equivalent to that obtained from the prone MRI.
- Conditions
- Breast Cancer
- Being tested
- Supine MRI
- Keywords
- Breast Cancer, Breast Conserving Surgery, Breast diagnostics, Breast imaging
- 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
A limitation of MRI studies of the breast is that MRI exams are performed with the patient prone and the breasts in a pendant position, which is markedly different than the position of the breast when the patient is supine on the Operating Room table. The spatial information the surgeon receives from the prone MRI about the site of the tumor in the breast is hard to mentally translate into the actual site of the tumor in the breast of a supine patient prepared for surgery.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 addition of supine MRI to conventional imaging | Active comparator | Arm 1 objective will be to determine whether the addition of supine MRI to conventional imaging with mammography and or sonography and prone MRI will result in a lower positive margin rate in patients undergoing breast conserving surgery. Receives: Device: Supine MRI |
| Arm 2 randomize to SOC vs supine MRI + SOC | Active comparator | Arm 2 of the study patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique. Receives: Device: Supine MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.
Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.
Measured: From baseline MRI to intraoperative measurements: 30 days
To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery.
The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria.
Measured: 30 days from surgery
Secondary outcomes (1)
Differences Between the Two Groups in the Volume of Breast Tissue Removed
The mean specimen volumes to be compared using t - statistics. The concordance between lesion volumes identified on the supine MRI images and the prone MRI images will be evaluated through correlation and regression analysis.
Measured: 30 days from surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study startSep 2009
- Primary completionMar 2018
- Study completionJul 2018
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 Dartmouth-Hitchcock Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929395
- Sponsor's protocol ID
- D0928
- Other IDs
- NCI-2011-03481
- Status last verified
- Apr 2019
- First submitted
- 5 Apr 2013
- Last updated
- 30 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Use of Supine MRI Images in Breast Conserving Surgery
- ClinicalTrials.gov ID
- NCT01929395
- Acronym / sponsor ID
- D0928
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Breast Conserving Surgery, Breast diagnostics, Breast imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- Sep 2009 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Posted 30 Apr 2019
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 2 Phase study. In the first phase of the study, patients with palpable invasive breast cancer underwent pre-operative supine MRI and optical scanning in the surgical position. In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.
Detailed description
We propose to use a novel technique (optical scanning) to correlate the supine MRI image to the surgical position in the OR and then to confirm and extend the Japanese study described above. In the first phase of the study, 5-25 patients with palpable invasive breast cancer will undergo pre-operative supine MRI and optical scanning in the surgical position. The purpose of this phase will be ensure that the images created from the optical scanner-adjusted supine MRI images closely correspond to the location of the palpable tumors in these breasts. All patients will then have their tumor resected using the standard method of either palpation or image guided wire localization. The first phase has been completed.
In the second phase of the study, patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique.
Our secondary objectives will be to determine:
- whether there are differences between the two groups in the volume of breast tissue removed.
- whether diagnostic information obtained from a supine MRI is equivalent to that obtained from the prone MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 addition of supine MRI to conventional imaging | Active comparator | Device: Supine MRIArm 1 objective will be to determine whether the addition of supine MRI to conventional imaging with mammography and or sonography and prone MRI will result in a lower positive margin rate in patients undergoing breast conserving surgery. |
| Arm 2 randomize to SOC vs supine MRI + SOC | Active comparator | Device: Supine MRIArm 2 of the study patients with non-palpable invasive breast cancer or DCIS who desire breast conservation will be randomized to either a usual care group, or a group receiving a supine MRI in addition to conventional imaging (mammogram and prone MRI) and undergoing breast cancer resection without the wire localization technique. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age greater than/equal to 18 years
- Histologic diagnosis of palpable invasive breast cancer or ductal carcinoma in situ
- Patient desire to undergo breast surgery
- 3. Patients will have provided informed consent to participate, documented by their signature on the study consent form 4. The cancer enhances on breast MRI imaging.
- Age greater than/equal to 18 years
Key exclusion criteria (6 listed)
- Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip or metallic foreign body in or near eyes
- Severe claustrophobia
- Contraindication to use of gadolinium based intravenous contrast, including life threatening allergy or compromised renal function (creatinine > 2.0)
- History of median sternotomy
- Pregnancy (Patient attestation that they are not pregnant will be acceptable, as per standard, as per standard policy for MRIs at DHMC).
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 MRIA limitation of MRI studies of the breast is that MRI exams are performed with the patient prone and the breasts in a pendant position, which is markedly different than the position of the breast when the patient is supine on the Operating Room table. The spatial information the surgeon receives from the prone MRI about the site of the tumor in the breast is hard to mentally translate into the actual site of the tumor in the breast of a supine patient prepared for surgery. | Device | Arm 1 addition of supine MRI to conventional imaging, Arm 2 randomize to SOC vs supine MRI + SOC |
Primary outcome
The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor.
Time frame: From baseline MRI to intraoperative measurements: 30 days
Mean calculated from differences in precise distances from the nipple to the superior, inferior, medial and lateral edges of the tumor as determined from the adjusted MRI images and conventional MRI.
To Determine Whether the Addition of Supine MRI to Conventional Imaging With Mammography and Prone MRI Results in a Lower Positive Margin Rate in Patients Undergoing Breast-conserving Surgery.
Time frame: 30 days from surgery
The primary analysis consists of computing the positive margin rate observed in the two groups and comparing them with a chi-squared test and finally comparing the proportion of patients with positive margins in the two groups based on study criteria.
1 secondary outcome
Differences Between the Two Groups in the Volume of Breast Tissue Removed
Time frame: 30 days from surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supine MRI in people with Breast Cancer, run by Dartmouth-Hitchcock Medical Center 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 10 inclusion and 6 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 30 Apr 2019. 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?
Yes. Results are posted in the registry (first posted 30 Apr 2019). 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?
The Mean Distance Between the Image-defined and Palpation-defined Edges of the Tumor. (time frame: From baseline MRI to intraoperative measurements: 30 days). The study lists 2 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 30 Apr 2019.