Breast Cancer FemaleNCT04242277
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
An observational study of Breast Cancer Female, run by Perimeter Medical Imaging at 2 sites in United States.
Trial summary
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology. 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?
- Investigational WF-OCT device
- Type of treatment
- Medical device
- How many people
- 198 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Aug 2020to 27 Jul 2021
- 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: Consented patients meeting eligibility criteria, undergoing breast conservation surgery.
Who may be able to join
- Female
- Age 18 years or older
- Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery
- May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation)
- Ability to understand and the willingness to sign a written informed consent document
Who cannot join
- Metastatic cancer (Stage IV)
- Lobular carcinoma as primary diagnosis
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Baylor College of Medicine
Houston, Texas, 77030
MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
Read the detailed description
Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.
- Conditions
- Breast Cancer Female
- Being tested
- Investigational WF-OCT device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational WF-OCT deviceDevice
Excised lumpectomy tissue will be imaged on an investigational WF-OCT device
| Study group | Role | What they receive |
|---|---|---|
| WF-OCT imaging of excised breast lumpectomy tissue | Excised lumpectomy tissue from all consented patients will be imaged on an investigational OCT-based device. No clinical decisions will be made based on the images acquired. Receives: Device: Investigational WF-OCT device |
What is being measured
The primary outcome is the main question the study is designed to answer.
WF-OCT image acquisition of excised lumpectomy tissue margins
This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start3 Aug 2020
- Primary completion27 Jul 2021
- Study completion27 Jul 2021
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.
- 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
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Perimeter Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Cancer Prevention Research Institute of Texas
- Responsible party
- Sponsor
- Investigators
- Savitri Krishnamurthy, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242277
- Sponsor's protocol ID
- PER-19-03
- Status last verified
- May 2023
- First submitted
- 23 Jan 2020
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.
- ClinicalTrials.gov ID
- NCT04242277
- Acronym / sponsor ID
- PER-19-03
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Perimeter Medical ImagingIndustry (pharma, biotech, devices)
- Collaborators
- Cancer Prevention Research Institute of Texas
- Study start
- 3 Aug 2020 (actual)
- Primary completion
- 27 Jul 2021 (actual)
- Study completion
- 27 Jul 2021 (actual)
- First posted
- 27 Jan 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.
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
Detailed description
Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WF-OCT imaging of excised breast lumpectomy tissue | – | Device: Investigational WF-OCT deviceExcised lumpectomy tissue from all consented patients will be imaged on an investigational OCT-based device. No clinical decisions will be made based on the images acquired. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consented patients meeting eligibility criteria, undergoing breast conservation surgery.
Key inclusion criteria (5 listed)
- Female
- Age 18 years or older
- Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery
- May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation)
- Ability to understand and the willingness to sign a written informed consent document
Key exclusion criteria (2 listed)
- Metastatic cancer (Stage IV)
- Lobular carcinoma as primary diagnosis
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 |
|---|---|---|
| Investigational WF-OCT deviceExcised lumpectomy tissue will be imaged on an investigational WF-OCT device | Device | WF-OCT imaging of excised breast lumpectomy tissue |
Primary outcome
WF-OCT image acquisition of excised lumpectomy tissue margins
Time frame: 1 year
This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins.
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 19 May 2023.
- 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.
Savitri Krishnamurthy, MD principal investigator
M.D. Anderson Cancer Center
2 sites 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 Perimeter Medical Imaging 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 5 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 19 May 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?
WF-OCT image acquisition of excised lumpectomy tissue margins (time frame: 1 year). 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 19 May 2023.