Breast CancerNCT01107080
Fast Spectral Imaging Device for Tumor Margin Mapping
An observational study of Breast Cancer, run by Duke University at 1 site in United States.
Trial summary
The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Sep 2011
- Phase
- Observational
- 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
Study population: There are 2 groups of patients and each group contains 20 participants.
Who may be able to join
- Patients undergoing a partial mastectomy or mastectomy for the treatment of an invasive or non-invasive breast malignancy
- Age > 18
- Clinically detectable disease either by physical examination or radiographic studies
- Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group.
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Patients considered in "vulnerable" populations
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
The objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. The proposed technology will be a multi-channel optical assay device for intra-operative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or mastectomy.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast carcinoma in situ, ductal breast carcinoma in situ, invasive carcinoma, invasive ductal carcinoma, invasive lobular carcinoma
- Medical subject headings
- Breast Neoplasms, Breast Carcinoma In Situ, Carcinoma, Intraductal, Noninfiltrating, Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Degradation | 30 mastectomy, partial mastectomy, and mammoplasty samples will be analyzed to define the effective post-excision time window in which the device must be used before the results can no longer be evaluated. The mammoplasty specimens are necessary to assess normal tissue outcomes. | |
| Reproducibility | 25 Partial Mastectomy cases will be analyzed to distinguish between different implementation methods of the technology. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To perform a critical evaluation of the device in a practical clinical setting
(1) In order to define the effective post-excision time window in which the device must be used, which ultimately has bearings on the final product indications for use. (2)To analyze the different methods of implementation of the technology.
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 posted20 Apr 2010 (estimated)
- Study startSep 2009
- Primary completionSep 2011
- Study completionSep 2011
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.
- More trials run by Duke UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nimmi Ramanujam, PhD, Study chair, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107080
- Sponsor's protocol ID
- Pro00017428
- Other IDs
- 2R42CA128160-02
- Status last verified
- Feb 2013
- First submitted
- 18 Apr 2010
- Last updated
- 7 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fast Spectral Imaging Device for Tumor Margin Mapping
- ClinicalTrials.gov ID
- NCT01107080
- Acronym / sponsor ID
- Pro00017428
- Conditions
- Breast Cancer
- Keywords
- breast cancer, breast carcinoma in situ, ductal breast carcinoma in situ, invasive carcinoma, invasive ductal carcinoma, invasive lobular carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- Sep 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Apr 2010 (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 objective of the proposed research is to develop a clinical-trial-ready device and to evaluate its practical utility as a routinely used intra-operative tool. Our multidisciplinary group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. The proposed technology will be a multi-channel optical assay device for intra-operative imaging of margins in specimens excised from patients undergoing breast conserving surgery (partial mastectomy) or mastectomy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Degradation | – | –30 mastectomy, partial mastectomy, and mammoplasty samples will be analyzed to define the effective post-excision time window in which the device must be used before the results can no longer be evaluated. The mammoplasty specimens are necessary to assess normal tissue outcomes. |
| Reproducibility | – | –25 Partial Mastectomy cases will be analyzed to distinguish between different implementation methods of the technology. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There are 2 groups of patients and each group contains 20 participants.
Key inclusion criteria (5 listed)
- Patients undergoing a partial mastectomy or mastectomy for the treatment of an invasive or non-invasive breast malignancy
- Age > 18
- Clinically detectable disease either by physical examination or radiographic studies
- Patients of all ethnic and gender groups will be included. Protocol accrual will be reviewed annually to include a determination of minority and gender representation. If accrual demonstrates under representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group.
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (1 listed)
- Patients considered in "vulnerable" populations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To perform a critical evaluation of the device in a practical clinical setting
Time frame: 2 years
(1) In order to define the effective post-excision time window in which the device must be used, which ultimately has bearings on the final product indications for use. (2)To analyze the different methods of implementation of the technology.
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 7 Feb 2013.
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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.
Nimmi Ramanujam, PhD study chair
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Duke University 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 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 7 Feb 2013. 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?
To perform a critical evaluation of the device in a practical clinical setting (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 7 Feb 2013.