Early Stage Breast CancerNCT02335671
Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
A study testing Intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometer Analysis of Tissue Sample in people with Early Stage Breast Cancer and Breast Cancer Stage I, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
The purpose of this study is to investigate the use of intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine if these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Early Stage Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
- What is being tested?
- Intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometer Analysis of Tissue Sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2015to Jan 2023
- 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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be female
- Participants must have a pre-operative standard mammogram with or without ultrasound. These may be performed at outside institutions.
- Participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at BWH/DFCI.
- Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for BCS, and the ability to undergo standard radiation therapy post-operatively).
- Patient must meet standard MRI guidelines and be able and willing to undergo MRI
- Age ≥18 years and < 75.
- 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 known Li-Fraumeni or Cowden's Disease.
- Participants with prior mantle radiation.
- Participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin.
- Participants who are pregnant.
- Participants who enroll in a preoperative therapy trial or who have been treated with neoadjuvant chemotherapy.
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- Participants with known active collagen vascular disease.
- Participants with prior history of ipsilateral breast carcinoma.
- Patients who have biopsy confirmed multi-centric disease.
- Participants who have documented contra-indications for contrast-enhanced MRI, including but not limited to renal failure.
- Participants who exceed the weight limit for the surgical table at AMIGO, 350 lbs or who will not fit into the 70 cm diameter bore of the MRI scanner at AMIGO or the 60 cm diameter bore of the pre-procedure imaging MRI scanner.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
The purpose of this study is to investigate the use of intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine if these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins.
Read the detailed description
This research study is a Phase II clinical trial investigating the use of intra-operative MRI and MS in breast cancer surgery. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
Prior research has shown that intraoperative MRI and MS are two types of tests that are feasible to use during cancer surgery and may be able to guide therapy. In this study, we are evaluating the accuracy of intra-operative MRI and MS in determining whether or not all cancer tissue was removed during breast surgery.
- Being tested
- Intra-operative Magnetic Resonance Imaging (MRI), Mass Spectrometer Analysis of Tissue Sample
- Keywords
- Early Stage Breast Cancer, Breast Conserving Surgery, Breast Cancer Stage I, Breast Cancer Stage II
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-operative Magnetic Resonance Imaging (MRI)Procedure or surgery
Mass Spectrometer Analysis of Tissue SampleOther
Analysis of Tissue Sample
| Study group | Role | What they receive |
|---|---|---|
| Intra-operative Magnetic Resonance Imaging (MRI) | Experimental | * Preoperative diagnostic MRI
* Intra-operative MRI
* Standard lumpectomy and sentinel node biopsy if indicated, or standard axillary dissection if clinically indicated
* Specimen to Pathology and Mass Spectrometer (Analysis of Tissue Sample) Receives: Procedure: Intra-operative Magnetic Resonance Imaging (MRI); Other: Mass Spectrometer Analysis of Tissue Sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the accuracy of MRI in detecting tumor boundaries
Measured: 2 Years
Secondary outcomes (3)
To determine the operating characteristics (sensitivity, specificity, negative predictive value and positive predictive value) of MRI in detecting tumor boundaries as confirmed with pathologic results
Measured: 2 Years
To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results.
Measured: 2 Years
To develop novel image processing algorithms to detect remnant tumor from intraoperative DCE-MRI in presence of tissue edema and reduced perfusion
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionJan 2023
- Study completionJan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thanh Barbie, MD, Dana-Farber Cancer Institute
- Investigators
- Thanh Barbie, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335671
- Sponsor's protocol ID
- 14-476
- Status last verified
- Feb 2023
- First submitted
- 7 Jan 2015
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Mass Spectrometry And Intraoperative MRI In The Advanced Multimodality Image Guided Operating Suite (Amigo) In Breast-Conserving Therapy
- ClinicalTrials.gov ID
- NCT02335671
- Acronym / sponsor ID
- 14-476
- Keywords
- Early Stage Breast Cancer, Breast Conserving Surgery, Breast Cancer Stage I, Breast Cancer Stage II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jan 2023 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 12 Jan 2015 (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 investigate the use of intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometry (MS) during breast conserving surgery, and to determine if these tests are capable of accurately predicting the presence or absence of breast tumor in surgical specimens at the margins.
Detailed description
This research study is a Phase II clinical trial investigating the use of intra-operative MRI and MS in breast cancer surgery. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
Prior research has shown that intraoperative MRI and MS are two types of tests that are feasible to use during cancer surgery and may be able to guide therapy. In this study, we are evaluating the accuracy of intra-operative MRI and MS in determining whether or not all cancer tissue was removed during breast surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intra-operative Magnetic Resonance Imaging (MRI) | Experimental | Procedure: Intra-operative Magnetic Resonance Imaging (MRI), Other: Mass Spectrometer Analysis of Tissue Sample* Preoperative diagnostic MRI * Intra-operative MRI * Standard lumpectomy and sentinel node biopsy if indicated, or standard axillary dissection if clinically indicated * Specimen to Pathology and Mass Spectrometer (Analysis of Tissue Sample) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be female
- Participants must have a pre-operative standard mammogram with or without ultrasound. These may be performed at outside institutions.
- Participants must have biopsy confirmed and clinical stage 1 or stage 2 breast carcinoma. If biopsy was done at an outside hospital, pathology will be reviewed at BWH/DFCI.
- Participants must be candidates for definitive local therapy with breast conserving therapy (this takes into account tumor to breast size ratio appropriate for BCS, and the ability to undergo standard radiation therapy post-operatively).
- Patient must meet standard MRI guidelines and be able and willing to undergo MRI
Key exclusion criteria (11 listed)
- Participants with a known BRCA 1 or 2 mutation.
- Participants with known Li-Fraumeni or Cowden's Disease.
- Participants with prior mantle radiation.
- Participants with locally advanced breast cancer such as inflammatory breast cancer or cancer grossly involving skin.
- 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 |
|---|---|---|
| Intra-operative Magnetic Resonance Imaging (MRI) | Procedure or surgery | Intra-operative Magnetic Resonance Imaging (MRI) |
| Mass Spectrometer Analysis of Tissue SampleAnalysis of Tissue Sample | Other | Intra-operative Magnetic Resonance Imaging (MRI) |
Primary outcome
To evaluate the accuracy of MRI in detecting tumor boundaries
Time frame: 2 Years
3 secondary outcomes
To determine the operating characteristics (sensitivity, specificity, negative predictive value and positive predictive value) of MRI in detecting tumor boundaries as confirmed with pathologic results
Time frame: 2 Years
To evaluate the correlation of intraoperative mass spectrometry results to tumor boundaries as confirmed with pathologic results.
Time frame: 2 Years
To develop novel image processing algorithms to detect remnant tumor from intraoperative DCE-MRI in presence of tissue edema and reduced perfusion
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
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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.
Thanh Barbie, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-operative Magnetic Resonance Imaging (MRI) and Mass Spectrometer Analysis of Tissue Sample in people with Early Stage Breast Cancer and Breast Cancer Stage I, 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 28 Feb 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To evaluate the accuracy of MRI in detecting tumor boundaries (time frame: 2 Years). 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 28 Feb 2023.