Breast CancerMarginProbeNCT02456649
Study of the Outcomes of Intraoperative Margin Assessment With MarginProbe
A study testing MarginProbe in people with Breast Cancer, run by Huntington Memorial Hospital at 1 site in United States.
Trial summary
The combination of breast conserving surgery (lumpectomy) with radiation therapy has been shown to result in equivalent overall survival rates compared to mastectomy for the local treatment of breast cancer. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MarginProbe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Sep 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Subjects able to read and understand the informed consent
Who cannot join
- 1. Subjects unable to read or understand the informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntington Memorial Hospital
Pasadena, California, 91105
About this study
Official title: A Phase II Study of the Outcomes of Intraoperative Margin Assessment With Adjunctive Use of MarginProbe in Addition to Standard
The combination of breast conserving surgery (lumpectomy) with radiation therapy has been shown to result in equivalent overall survival rates compared to mastectomy for the local treatment of breast cancer. As a result, the majority of patients diagnosed with breast cancer in the United States undergo lumpectomy as their primary surgical therapy. Multiple studies have demonstrated the association between positive lumpectomy margins and an increased risk of ipsilateral breast tumor recurrence, even with postoperative radiation. Studies report 20-40% of lumpectomy procedures result in one or more involved (positive) surgical margins, leading to the need for further surgery, emotional distress, poorer cosmesis, delay to adjuvant treatments, and increased cost. Current available intraoperative margin assessment techniques include specimen Xray, gross pathology, frozen section, and touch prep cytology. To reduce the incidence of positive margins, the MarginProbe (Dune Medical Devices, Caesarea, Israel) was developed to provide real-time, intraoperative assessment of the presence of tumor at the lumpectomy margin. In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures.
Read the detailed description
In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures.
Aims of the study:
Primary objectives
- Determine positive margin rate following lumpectomy
Secondary objectives
- Determine accuracy of intraoperative margin assessment with use of MarginProbe plus standard of care (gross pathologic examination and/or intraoperative specimen Xray) versus standard of care (gross pathologic examination and/or intraoperative specimen Xray) alone.
- Determine impact of MarginProbe on total tissue volume removed
- Determine the impact of MarginProbe on the need for additional surgical procedures.
- Conditions
- Breast Cancer
- Being tested
- MarginProbe
- Keywords
- lumpectomy margins
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MarginProbeDevice
Intraoperative MarginProbe use as adjunct to standard practice MarginProbe will be used on the lumpectomy specimen within 20 minutes of excision, prior to specimen Xray or gross pathology evaluation. This may take up to 5 minutes. MarginProbe will indicate a positive or negative reading for each of the 6 circumferential margins, and the results will be recorded. Any margins determined by to < 5-10 mm by specimen Xray or gross pathology examination will be re-excised. In addition, any additional margins not already identified as < 5-10 mm, but identified as positive by MarginProbe will be re-excised where feasible.
| Study group | Role | What they receive |
|---|---|---|
| MarginProbe | Experimental | Single arm study - MarginProbe in addition to standard procedure Receives: Device: MarginProbe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients with histologically positive surgical margins
Measured: 2 weeks after surgery
Secondary outcomes (2)
Percentage of patients who undergo a second surgery after initial lumpectomy.
Measured: 2 weeks after surgery
False positive and false negative rate of Intraop MarginProbe results compared to histologic evaluation
Measured: 2 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huntington Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeannie Shen, Huntington Memorial Hospital
- Investigators
- Jeannie Shen, MD, Principal investigator, Huntington Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456649
- Sponsor's protocol ID
- HMH2015.001
- Acronym
- MarginProbe
- Status last verified
- Sep 2016
- First submitted
- 19 May 2015
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Moran MS, Schnitt SJ, Giuliano AE, et al. JCO Feb 10, 2014.
Allweis TM, Kaufman Z, Lelcuk S, Pappo I, Karni T, Schneebaum S, Spector R, Schindel A, Hershko D, Zilberman M, Sayfan J, Berlin Y, Hadary A, Olsha O, Paran H, Gutman M, Carmon M. A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery. Am J Surg. 2008 Oct;196(4):483-9. doi: 10.1016/j.amjsurg.2008.06.024.
PubMed 18809049Pappo I, Spector R, Schindel A, Morgenstern S, Sandbank J, Leider LT, Schneebaum S, Lelcuk S, Karni T. Diagnostic performance of a novel device for real-time margin assessment in lumpectomy specimens. J Surg Res. 2010 May 15;160(2):277-81. doi: 10.1016/j.jss.2009.02.025. Epub 2009 Mar 31.
PubMed 19628225Rivera RJ, Holmes DR, Tafra L. Analysis of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe versus Standard of Care on Tissue Volume Removed. Int J Surg Oncol. 2012;2012:868623. doi: 10.1155/2012/868623. Epub 2012 Dec 26.
PubMed 23326653Thill M, Dittmer C, Baumann K, Friedrichs K, Blohmer JU. MarginProbe(R)--final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ. Breast. 2014 Feb;23(1):94-6. doi: 10.1016/j.breast.2013.11.002. Epub 2013 Dec 2.
PubMed 24291375Schnabel F, Boolbol SK, Gittleman M, Karni T, Tafra L, Feldman S, Police A, Friedman NB, Karlan S, Holmes D, Willey SC, Carmon M, Fernandez K, Akbari S, Harness J, Guerra L, Frazier T, Lane K, Simmons RM, Estabrook A, Allweis T. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. 2014 May;21(5):1589-95. doi: 10.1245/s10434-014-3602-0. Epub 2014 Mar 5.
PubMed 24595800Police AM. Routine use of a real time margin assessment device. Poster Abstract presented at the 31st Annual Miami Breast Cancer Conference; May 2014.
Sebastian M, Akbari S. Combined experience at three breast centers with routine use of an intraoperative margin assessment device including comparison to historical re-excision rates. Poster Abstract presented at ASCO Breast Cancer Symposium; September 2014.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of the Outcomes of Intraoperative Margin Assessment With Adjunctive Use of MarginProbe in Addition to Standard
- ClinicalTrials.gov ID
- NCT02456649
- Acronym / sponsor ID
- MarginProbe / HMH2015.001
- Conditions
- Breast Cancer
- Keywords
- lumpectomy margins
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Huntington Memorial HospitalUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 28 May 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 combination of breast conserving surgery (lumpectomy) with radiation therapy has been shown to result in equivalent overall survival rates compared to mastectomy for the local treatment of breast cancer. As a result, the majority of patients diagnosed with breast cancer in the United States undergo lumpectomy as their primary surgical therapy. Multiple studies have demonstrated the association between positive lumpectomy margins and an increased risk of ipsilateral breast tumor recurrence, even with postoperative radiation. Studies report 20-40% of lumpectomy procedures result in one or more involved (positive) surgical margins, leading to the need for further surgery, emotional distress, poorer cosmesis, delay to adjuvant treatments, and increased cost. Current available intraoperative margin assessment techniques include specimen Xray, gross pathology, frozen section, and touch prep cytology. To reduce the incidence of positive margins, the MarginProbe (Dune Medical Devices, Caesarea, Israel) was developed to provide real-time, intraoperative assessment of the presence of tumor at the lumpectomy margin. In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures.
Detailed description
In the current study, the investigators aim to determine the effectiveness of MarginProbe as an adjunctive tool to standard practice for intraoperative identification of tumor at lumpectomy margins, and its ability to reduce positive margins and decrease the need for additional surgical procedures.
Aims of the study:
Primary objectives
- Determine positive margin rate following lumpectomy
Secondary objectives
- Determine accuracy of intraoperative margin assessment with use of MarginProbe plus standard of care (gross pathologic examination and/or intraoperative specimen Xray) versus standard of care (gross pathologic examination and/or intraoperative specimen Xray) alone.
- Determine impact of MarginProbe on total tissue volume removed
- Determine the impact of MarginProbe on the need for additional surgical procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MarginProbe | Experimental | Device: MarginProbeSingle arm study - MarginProbe in addition to standard procedure |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Subjects able to read and understand the informed consent
Key exclusion criteria (1 listed)
- 1. Subjects unable to read or understand the informed consent.
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 |
|---|---|---|
| MarginProbeIntraoperative MarginProbe use as adjunct to standard practice MarginProbe will be used on the lumpectomy specimen within 20 minutes of excision, prior to specimen Xray or gross pathology evaluation. This may take up to 5 minutes. MarginProbe will indicate a positive or negative reading for each of the 6 circumferential margins, and the results will be recorded. Any margins determined by to < 5-10 mm by specimen Xray or gross pathology examination will be re-excised. In addition, any additional margins not already identified as < 5-10 mm, but identified as positive by MarginProbe will be re-excised where feasible. | Device | MarginProbe |
Primary outcome
Percentage of patients with histologically positive surgical margins
Time frame: 2 weeks after surgery
2 secondary outcomes
Percentage of patients who undergo a second surgery after initial lumpectomy.
Time frame: 2 weeks after surgery
False positive and false negative rate of Intraop MarginProbe results compared to histologic evaluation
Time frame: 2 weeks after surgery
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 4 Oct 2016.
- BackgroundMoran MS, Schnitt SJ, Giuliano AE, et al. JCO Feb 10, 2014.
- Results publication: PubMed 18809049Allweis TM, Kaufman Z, Lelcuk S, Pappo I, Karni T, Schneebaum S, Spector R, Schindel A, Hershko D, Zilberman M, Sayfan J, Berlin Y, Hadary A, Olsha O, Paran H, Gutman M, Carmon M. A prospective, randomized, controlled, multicenter study of a real-time, intraoperative probe for positive margin detection in breast-conserving surgery. Am J Surg. 2008 Oct;196(4):483-9. doi: 10.1016/j.amjsurg.2008.06.024.
- Results publication: PubMed 19628225Pappo I, Spector R, Schindel A, Morgenstern S, Sandbank J, Leider LT, Schneebaum S, Lelcuk S, Karni T. Diagnostic performance of a novel device for real-time margin assessment in lumpectomy specimens. J Surg Res. 2010 May 15;160(2):277-81. doi: 10.1016/j.jss.2009.02.025. Epub 2009 Mar 31.
- Results publication: PubMed 23326653Rivera RJ, Holmes DR, Tafra L. Analysis of the Impact of Intraoperative Margin Assessment with Adjunctive Use of MarginProbe versus Standard of Care on Tissue Volume Removed. Int J Surg Oncol. 2012;2012:868623. doi: 10.1155/2012/868623. Epub 2012 Dec 26.
- Results publication: PubMed 24291375Thill M, Dittmer C, Baumann K, Friedrichs K, Blohmer JU. MarginProbe(R)--final results of the German post-market study in breast conserving surgery of ductal carcinoma in situ. Breast. 2014 Feb;23(1):94-6. doi: 10.1016/j.breast.2013.11.002. Epub 2013 Dec 2.
- Results publication: PubMed 24595800Schnabel F, Boolbol SK, Gittleman M, Karni T, Tafra L, Feldman S, Police A, Friedman NB, Karlan S, Holmes D, Willey SC, Carmon M, Fernandez K, Akbari S, Harness J, Guerra L, Frazier T, Lane K, Simmons RM, Estabrook A, Allweis T. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. 2014 May;21(5):1589-95. doi: 10.1245/s10434-014-3602-0. Epub 2014 Mar 5.
- Results publicationPolice AM. Routine use of a real time margin assessment device. Poster Abstract presented at the 31st Annual Miami Breast Cancer Conference; May 2014.
- Results publicationSebastian M, Akbari S. Combined experience at three breast centers with routine use of an intraoperative margin assessment device including comparison to historical re-excision rates. Poster Abstract presented at ASCO Breast Cancer Symposium; September 2014.
- 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.
Jeannie Shen, MD principal investigator
Huntington Memorial 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 MarginProbe in people with Breast Cancer, run by Huntington Memorial Hospital 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 1 inclusion and 1 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 4 Oct 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 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?
Percentage of patients with histologically positive surgical margins (time frame: 2 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02456649, which also lists 8 linked publications.
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 4 Oct 2016.