Breast CancerNCT07140965
The Impact of Surgeon-Interpreted Intraoperative Margin Assessment During Breast Conserving Surgery on Postoperative Treatment
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn if Pegulicianine Fluorescence-Guided Surgery (pFGS), which is part of the Lumicell Direct Visualization System, and Digital Breast Tomosynthesis (DBT) can improve the identification of tumor margins during a partial mastectomy and decrease the need for a second surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pegulicianine Fluorescence-Guided Surgery, Digital Breast Tomosynthesis and Breast Conserving Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2025to 30 Sep 2029
- 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: MD Anderson Cancer Center
Who may be able to join
- We plan to enroll 175 patients.
- Women aged 18 years or older with a breast cancer diagnosis at any stage who will undergo a segmental mastectomy, regardless of receipt of neoadjuvant therapy.
Who cannot join
- Multi-site segmental mastectomies within the same breast
- Participants without a cancer diagnosis
- Participants from vulnerable populations including minors, pregnant women, and/or cognitively impaired adults.
Trial locations and contacts
1 site in 1 country.
About this study
To learn if Pegulicianine Fluorescence-Guided Surgery (pFGS), which is part of the Lumicell Direct Visualization System, and Digital Breast Tomosynthesis (DBT) can improve the identification of tumor margins during a partial mastectomy and decrease the need for a second surgery.
Read the detailed description
Primary Objectives:
-To determine if surgeon interpretation of pFGS and DBT has a higher specificity compared to SEP, resulting in fewer excisions of additional tissue unnecessarily
Secondary Objectives:
- To determine if surgeon evaluation of segmental mastectomy margins using pFGS and DBT is associated with better patient- and physician-reported cosmesis
- To determine if surgeon interpretation of pFGS and DBT results in a lower rate of positive margins after BCS compared to SEP
- To determine if surgeon interpretation of pFGS and DBT has a shorter operative time compared to SEP.
- To determine if surgeon interpretation of pFGS and DBT results in less delays in receipt of adjuvant treatment and the reduction of targeted volume of radiation therapy or omission of radiation altogether
- Conditions
- Breast Cancer
- Being tested
- Pegulicianine Fluorescence-Guided Surgery, Digital Breast Tomosynthesis, Breast Conserving Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pegulicianine Fluorescence-Guided SurgeryProcedure or surgery
Given by Surgery
Digital Breast TomosynthesisProcedure or surgery
Given by Procedure
Breast Conserving TherapyProcedure or surgery
Given by Procedure
| Study group | Role | What they receive |
|---|---|---|
| Intraoperative Margin Assessment | Utilizing Intraoperative Margin Assessment during the breast conserving surgery, using pFGS as well as DBT. Receives: Procedure: Pegulicianine Fluorescence-Guided Surgery; Procedure: Digital Breast Tomosynthesis; Procedure: Breast Conserving Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start9 Oct 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2029 (estimated)
Why it stopped: PI Request
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 M.D. Anderson Cancer 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
- 175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fedra Fallahian, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140965
- Sponsor's protocol ID
- 2025-0648
- Other IDs
- NCI-2025-06199
- Status last verified
- Oct 2026
- First submitted
- 21 Aug 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Surgeon-Interpreted Intraoperative Margin Assessment During Breast Conserving Surgery on Postoperative Treatment
- ClinicalTrials.gov ID
- NCT07140965
- Acronym / sponsor ID
- 2025-0648
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: PI Request
- Enrolment
- 175 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 26 Aug 2025 (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.
To learn if Pegulicianine Fluorescence-Guided Surgery (pFGS), which is part of the Lumicell Direct Visualization System, and Digital Breast Tomosynthesis (DBT) can improve the identification of tumor margins during a partial mastectomy and decrease the need for a second surgery.
Detailed description
Primary Objectives:
-To determine if surgeon interpretation of pFGS and DBT has a higher specificity compared to SEP, resulting in fewer excisions of additional tissue unnecessarily
Secondary Objectives:
- To determine if surgeon evaluation of segmental mastectomy margins using pFGS and DBT is associated with better patient- and physician-reported cosmesis
- To determine if surgeon interpretation of pFGS and DBT results in a lower rate of positive margins after BCS compared to SEP
- To determine if surgeon interpretation of pFGS and DBT has a shorter operative time compared to SEP.
- To determine if surgeon interpretation of pFGS and DBT results in less delays in receipt of adjuvant treatment and the reduction of targeted volume of radiation therapy or omission of radiation altogether
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intraoperative Margin Assessment | – | Procedure: Pegulicianine Fluorescence-Guided Surgery, Procedure: Digital Breast Tomosynthesis, Procedure: Breast Conserving TherapyUtilizing Intraoperative Margin Assessment during the breast conserving surgery, using pFGS as well as DBT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MD Anderson Cancer Center
Key inclusion criteria (2 listed)
- We plan to enroll 175 patients.
- Women aged 18 years or older with a breast cancer diagnosis at any stage who will undergo a segmental mastectomy, regardless of receipt of neoadjuvant therapy.
Key exclusion criteria (3 listed)
- Multi-site segmental mastectomies within the same breast
- Participants without a cancer diagnosis
- Participants from vulnerable populations including minors, pregnant women, and/or 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 |
|---|---|---|
| Pegulicianine Fluorescence-Guided SurgeryGiven by Surgery | Procedure or surgery | Intraoperative Margin Assessment |
| Digital Breast TomosynthesisGiven by Procedure | Procedure or surgery | Intraoperative Margin Assessment |
| Breast Conserving TherapyGiven by Procedure | Procedure or surgery | Intraoperative Margin Assessment |
Primary outcome
safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0
Time frame: Through study completion; an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Fedra Fallahian, MD principal investigator
M.D. Anderson Cancer Center
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 M.D. Anderson Cancer 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 2 inclusion and 3 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: paused, as of the sponsor's last update on 7 Oct 2026. 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?
Results are not available in the source record.
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?
safety and adverse events (AEs). Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 6.0 (time frame: Through study completion; an average of 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 7 Oct 2026.