Breast CancerNCT01372631
A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
A study testing miniature spectral imaging system, Bench-top optical spectrometer and High resolution microendoscope in people with Breast Cancer, run by Duke University at 2 sites in United States.
Trial summary
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. 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?
- miniature spectral imaging system, Bench-top optical spectrometer and High resolution microendoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to 1 Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing a reduction mammoplasty OR
- Patients undergoing a lumpectomy 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
2 sites in 1 country.
United States2 sites
Duke University Medical Center
Durham, North Carolina, 27708
University of Wisconsin - Madison
Madison, Wisconsin, 54706
About this study
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.
Read the detailed description
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.
Last patient's surgery took place in 2017 and recruitment remained open. Later the team encountered staffing issues; therefore the study status was updated to suspended. We recently made the decision to no longer attempt to enroll the remaining 2 subjects and focus on the data analysis only.
- Conditions
- Breast Cancer
- Being tested
- miniature spectral imaging system, Bench-top optical spectrometer, High resolution microendoscope
- Keywords
- Reduction mammoplasty, mastectomy, partial mastectomy, lumpectomy, breast conserving surgery, 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.
miniature spectral imaging systemDevice
Use of miniature spectral imaging system
Bench-top optical spectrometerDevice
Use of bench-top optical spectrometer
High resolution microendoscopeDevice
Use of high resolution microendoscope
| Study group | Role | What they receive |
|---|---|---|
| Pressure assessment | Experimental | 30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements. Receives: Device: miniature spectral imaging system; Device: Bench-top optical spectrometer |
| Random and Systematic Errors | Experimental | 40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system. Receives: Device: miniature spectral imaging system; Device: Bench-top optical spectrometer |
| Sensitivity and Specificity Assessment | Experimental | 150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system. Receives: Device: miniature spectral imaging system; Device: Bench-top optical spectrometer; Device: High resolution microendoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of the optical signatures in breast tissue
Measured: Day of procedure (less than 10 minutes)
Secondary outcomes (1)
Sensitivity and Specificity of the device
Measured: Day of procedure (less than 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startApr 2011
- Primary completion1 Apr 2017
- Study completion1 Apr 2017
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Nimmi Ramanujam, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372631
- Sponsor's protocol ID
- Pro00028284
- Other IDs
- 5R01EB011574
- Status last verified
- Jun 2020
- First submitted
- 12 Jun 2011
- Last updated
- 10 Feb 2021
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Optical Spectral Imaging System for Imaging Breast Tumor Margins
- ClinicalTrials.gov ID
- NCT01372631
- Acronym / sponsor ID
- Pro00028284
- Conditions
- Breast Cancer
- Keywords
- Reduction mammoplasty, mastectomy, partial mastectomy, lumpectomy, breast conserving surgery, breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- Apr 2011
- Primary completion
- 1 Apr 2017 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 14 Jun 2011 (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 goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens.
Detailed description
The goal of this research is to further develop novel optical assay systems for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. We are seeking to establish the accuracy of first and second-generation prototypes of technologies utilizing optical spectroscopy for intra operative margin assessment in partial mastectomy or mastectomy specimens. The aims associated with this research are as follows, (1) to evaluate the device-tissue interface on reduction mammoplasty specimens from a total of 20 patients, (2) to assess random and systematic errors of the new miniature system on mastectomy specimens from a total of 40 patients (3) to test the sensitivity, and specificity of the miniature spectral imaging system for margin assessment on excised partial mastectomy or mastectomy specimens from a total of 150 patients undergoing breast conserving surgery.
Last patient's surgery took place in 2017 and recruitment remained open. Later the team encountered staffing issues; therefore the study status was updated to suspended. We recently made the decision to no longer attempt to enroll the remaining 2 subjects and focus on the data analysis only.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pressure assessment | Experimental | Device: miniature spectral imaging system, Device: Bench-top optical spectrometer30 patients undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled to assess the ideal pressure that should be applied when taking optical measurements. |
| Random and Systematic Errors | Experimental | Device: miniature spectral imaging system, Device: Bench-top optical spectrometer40 patients undergoing lumpectomy or mastectomy will be enrolled to assess the random and systematic errors of the miniature spectral imaging system. |
| Sensitivity and Specificity Assessment | Experimental | Device: miniature spectral imaging system, Device: Bench-top optical spectrometer, Device: High resolution microendoscope150 patient undergoing lumpectomy, mastectomy or reduction mammoplasty will be enrolled in order to determine the sensitivity and specificity of the miniature spectral imaging system. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients undergoing a reduction mammoplasty OR
- Patients undergoing a lumpectomy 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
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| miniature spectral imaging systemUse of miniature spectral imaging system | Device | Pressure assessment, Random and Systematic Errors, Sensitivity and Specificity Assessment |
| Bench-top optical spectrometerUse of bench-top optical spectrometer | Device | Pressure assessment, Random and Systematic Errors, Sensitivity and Specificity Assessment |
| High resolution microendoscopeUse of high resolution microendoscope | Device | Sensitivity and Specificity Assessment |
Primary outcome
Identification of the optical signatures in breast tissue
Time frame: Day of procedure (less than 10 minutes)
1 secondary outcome
Sensitivity and Specificity of the device
Time frame: Day of procedure (less than 10 minutes)
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 10 Feb 2021.
- Individual participant dataSharing planned: Undecided
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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, Ph.D. principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing miniature spectral imaging system, Bench-top optical spectrometer and High resolution microendoscope in people with Breast Cancer, run by Duke University 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 6 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 10 Feb 2021. 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?
Identification of the optical signatures in breast tissue (time frame: Day of procedure (less than 10 minutes)). 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 10 Feb 2021.