Breast Cancer FemaleNCT04257799
Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging
An observational study of Breast Cancer Female, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to test a new surgical imaging system called "Structured Light Imaging (SLI)." This system is designed to examine tissue removed during breast cancer surgery to see whether the tissue's edges contain cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Structured Light Imaging (SLI) System
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 16 Mar 2022
- 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: The investigators estimate that 100 women will be required. Based on the studies presented in the Introduction, the investigators expect 20% of breast cancer patients to have a positive margin. Based on historical operative volumes, the investigators anticipate recruiting 2 breast cancer patients per week. Thus it will take one year to accrue 100 patients to the study.
Who may be able to join
- Females 18 years of age or older.
- Histologic diagnosis of invasive breast cancer based on pre-surgical core biopsy.
- Scheduled for breast conserving surgery in the Dartmouth-Hitchcock (DH) Outpatient Surgical Center
- Ability to give an informed consent.
Who cannot join
- Patients who will have an expected specimen size greater than the specimen holder (i.e. > 10 X 10 X 5 cm).
- Prisoners and cognitively impaired adults.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
About this study
The purpose of this study is to test a new surgical imaging system called "Structured Light Imaging (SLI)." This system is designed to examine tissue removed during breast cancer surgery to see whether the tissue's edges contain cancer. The current standard of practice is to remove the breast tumor tissue and send the tissue to the lab for analysis following surgery. One in five women (in the US) must later return for a second surgery to remove cancer cells that the lab found remaining in the tissue.
In this study, researchers hope that the new SLI system may detect the cancer cells in the tissue's edges by imaging at the time of surgery. If successful, in the future we may use this system to improve entire cancer removal at the time of surgery, and reduce the need to perform a second surgery to remove additional breast tissue.
Read the detailed description
On the day of surgery, the surgeon will remove the patient's cancerous tissue, and then in a separate room near the operating room, imaging staff will test it with the Structured Light Imaging system. The testing may take several extra minutes to capture the images. After this imaging, the surgeon will complete the surgery. Following surgery, and per routine medical care, the patient's breast tumor tissue sample will be sent to DHMC's lab for testing. The patient will see her primary doctor for standard surgery follow-up.
No additional imaging or testing will be required for this research study following the usual surgery.
- Conditions
- Breast Cancer Female
- Being tested
- Structured Light Imaging (SLI) System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Light Imaging (SLI) SystemOther
Investigation of SLI and Tomographic Imaging to see if they will identify cancer cells at the edge of tissue specimens removed during the operation.
| Study group | Role | What they receive |
|---|---|---|
| Women with breast cancer diagnosis | Women with diagnosis of invasive breast cancer based on pre-surgical biopsy, and scheduled for breast-conserving surgery in the Dartmouth-Hitchcock (DH) Outpatient Surgical Center. Receives: Other: Structured Light Imaging (SLI) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of 3D tomography-SLI as measured by concurrence with standard of care 2-D mammography
Two surfaces (anterior and posterior) will be evaluated by SLI and 6 surfaces (anterior, posterior, medial, lateral, cranial, and caudal) will be evaluated by 3D tomography. Four surfaces are evaluated by standard-of-care 2-dimensional specimen mammography: medial, lateral, cranial and caudal to evaluate for the presence of cancer at the margin. Since anterior and posterior surfaces will be evaluated by both 3D tomography and SLI, an anterior or posterior margin will be considered positive only if it is positive by both 3D tomography and SLI. Otherwise the margin will be considered negative.
Sensitivity will be computed as True Positive (TP)/TP + False Negative (FN) results, compared to pathology. Specificity will be computed as True Negative (TN)/TN + False Positive (FP) results, compared to pathology.
Measured: Day of surgery
Secondary outcomes (4)
Sensitivity and Specificity of 3D tomography alone in identifying true positive margins and true negative margins
Sensitivity will be computed as True Positive (TP)/TP + False Negative (FN) results compared to pathology. Specificity will be computed as True Negative (TN)/TN + False Positive (FP) results compared to pathology.
Measured: Day of Surgery
Sensitivity and Specificity of SLI alone in identifying true positive margins and true negative margins
Sensitivity will be computed as True Positive (TP)/TP + False Negative (FN) results compared to pathology. Specificity will be computed as True Negative (TN)/TN + False Positive (FP) results compared to pathology.
Measured: Day of Surgery
Sensitivity and Specificity of standard-of-care 2D specimen mammography
The investigators will calculate the sensitivity and specificity of standard-of-care 2D specimen mammography and compare that to the combination of 3D tomography and SLI. Sensitivity will be computed as TP/TP + FN results compared to pathology. Specificity will be computed as TN/TN + FP results compared to pathology.
Measured: Day of Surgery
Determine the logistics of use of the imaging system, software interface and specimen holder.
The investigators will determine the logistics of use of the imaging system, software interface and specimen holder for possible future refinement.
Measured: Day of Surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start6 Feb 2020
- Primary completion16 Mar 2022
- Study completion16 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Trustees of Dartmouth College
- Responsible party
- Principal investigator, Richard J. Barth,Jr., Dartmouth-Hitchcock Medical Center
- Investigators
- Richard J Barth Jr., MD, Principal investigator, DHMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257799
- Sponsor's protocol ID
- D19160
- Status last verified
- Jun 2022
- First submitted
- 4 Feb 2020
- Last updated
- 22 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lumpectomy Specimen Margin Evaluation With Tomography and Structured Light Imaging
- ClinicalTrials.gov ID
- NCT04257799
- Acronym / sponsor ID
- D19160
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Trustees of Dartmouth College
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 16 Mar 2022 (actual)
- First posted
- 6 Feb 2020 (actual)
- 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 test a new surgical imaging system called "Structured Light Imaging (SLI)." This system is designed to examine tissue removed during breast cancer surgery to see whether the tissue's edges contain cancer. The current standard of practice is to remove the breast tumor tissue and send the tissue to the lab for analysis following surgery. One in five women (in the US) must later return for a second surgery to remove cancer cells that the lab found remaining in the tissue.
In this study, researchers hope that the new SLI system may detect the cancer cells in the tissue's edges by imaging at the time of surgery. If successful, in the future we may use this system to improve entire cancer removal at the time of surgery, and reduce the need to perform a second surgery to remove additional breast tissue.
Detailed description
On the day of surgery, the surgeon will remove the patient's cancerous tissue, and then in a separate room near the operating room, imaging staff will test it with the Structured Light Imaging system. The testing may take several extra minutes to capture the images. After this imaging, the surgeon will complete the surgery. Following surgery, and per routine medical care, the patient's breast tumor tissue sample will be sent to DHMC's lab for testing. The patient will see her primary doctor for standard surgery follow-up.
No additional imaging or testing will be required for this research study following the usual surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with breast cancer diagnosis | – | Other: Structured Light Imaging (SLI) SystemWomen with diagnosis of invasive breast cancer based on pre-surgical biopsy, and scheduled for breast-conserving surgery in the Dartmouth-Hitchcock (DH) Outpatient Surgical Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators estimate that 100 women will be required. Based on the studies presented in the Introduction, the investigators expect 20% of breast cancer patients to have a positive margin. Based on historical operative volumes, the investigators anticipate recruiting 2 breast cancer patients per week. Thus it will take one year to accrue 100 patients to the study.
Key inclusion criteria (4 listed)
- Females 18 years of age or older.
- Histologic diagnosis of invasive breast cancer based on pre-surgical core biopsy.
- Scheduled for breast conserving surgery in the Dartmouth-Hitchcock (DH) Outpatient Surgical Center
- Ability to give an informed consent.
Key exclusion criteria (2 listed)
- Patients who will have an expected specimen size greater than the specimen holder (i.e. > 10 X 10 X 5 cm).
- Prisoners and cognitively impaired adults.
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 |
|---|---|---|
| Structured Light Imaging (SLI) SystemInvestigation of SLI and Tomographic Imaging to see if they will identify cancer cells at the edge of tissue specimens removed during the operation. | Other | Women with breast cancer diagnosis |
Primary outcome
Sensitivity and Specificity of 3D tomography-SLI as measured by concurrence with standard of care 2-D mammography
Time frame: Day of surgery
Two surfaces (anterior and posterior) will be evaluated by SLI and 6 surfaces (anterior, posterior, medial, lateral, cranial, and caudal) will be evaluated by 3D tomography. Four surfaces are evaluated by standard-of-care 2-dimensional specimen mammography: medial, lateral, cranial and caudal to evaluate for the presence of cancer at the margin. Since anterior and posterior surfaces will be evaluated by both 3D tomography and SLI, an anterior or posterior margin will be considered positive only if it is positive by both 3D tomography and SLI. Otherwise the margin will be considered negative. Sensitivity will be computed as True Positive (TP)/TP + False Negative (FN) results, compared to pathology. Specificity will be computed as True Negative (TN)/TN + False Positive (FP) results, compared to pathology.
4 secondary outcomes
Sensitivity and Specificity of 3D tomography alone in identifying true positive margins and true negative margins
Time frame: Day of Surgery
Sensitivity and Specificity of SLI alone in identifying true positive margins and true negative margins
Time frame: Day of Surgery
Sensitivity and Specificity of standard-of-care 2D specimen mammography
Time frame: Day of Surgery
Determine the logistics of use of the imaging system, software interface and specimen holder.
Time frame: Day of 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 22 Jun 2022.
- 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.
Richard J Barth Jr., MD principal investigator
DHMC
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 Female, 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 4 inclusion and 2 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 22 Jun 2022. 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?
Sensitivity and Specificity of 3D tomography-SLI as measured by concurrence with standard of care 2-D mammography (time frame: Day of surgery). 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 22 Jun 2022.