Breast CancerPhase 2NCT03321929

Intraoperative Detection of Residual Cancer in Breast Cancer

A Phase 2 study testing LUM Imaging System in people with Breast Cancer, run by Lumicell, Inc. at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: LUM Imaging System
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 234 participants
Where: 16 sitesUnited States
Study dates: 6 Feb 2018to 10 Apr 2020
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or a combination of invasive breast cancer and DCIS. The protocol accepted methods for obtaining the histological samples are diagnostic core needle biopsies or fine needle biopsies.
Female, age of 18 years or older. Because no dosing or adverse event data are currently available on the use of LUM015 in subjects <18 years of age, children are excluded from this study.
Subjects must be scheduled for a lumpectomy for a breast malignancy.
Subjects must be able and willing to follow study procedures and instructions.
Subjects must have received and signed an informed consent form.
Subjects must have no uncontrolled serious medical problems except for the diagnosis of cancer, as per the exclusion criteria listed below.

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Subjects must have normal organ and marrow function within limits as defined below:
Leukocytes > 3,000/mcL
Platelets > 75,000/mcL
total bilirubin within normal institutional limits
AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
Creatinine ≤ 1.5 mg/dL or creatinine clearance > 60 mL/min/1.73 m2 for subjects with creatinine levels above institutional normal.

Who cannot join

Subjects who are treated for bilateral breast cancer resection procedure.
Subjects who are pregnant at the time of diagnosis of their breast cancer; this exclusion is necessary because the teratogenic properties of LUM015 are unknown. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with LUM015, breastfeeding should be discontinued if the mother is treated with LUM015.
Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Breast cancer patients are routinely advised against becoming pregnant during treatment, so this requirement does not differ from standard of care.
Subjects who have taken an investigational drug within 30 days of enrollment.
Subjects with prolonged QTc interval defined as greater than 480 ms.
Subjects who will have administration of methylene blue or any dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.

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Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.
Subjects with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN should be stable within these ranges while under pharmaceutical therapy.
History of allergic reaction attributed to drugs containing polyethylene glycol (PEG).
History of allergic reaction to any oral or intravenous contrast agents.
Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements.
HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with LUM015.
Any subject for whom the investigator feels participation is not in the best interest of the subject.
Subjects undergoing a second lumpectomy procedure because of positive margins in a previous surgery prior to entering this study.
Subjects with prior ipsilateral breast cancer surgeries, mastectomies, breast reconstructions or implants.
Subjects who have undergone a surgical biopsy for any reason in the ipsilateral breast performed less than 2 years prior to enrollment of this study.
Subjects with prior ipsilateral reduction mammoplasties (breast reductions) performed less than 2 years prior to enrollment to this study.
Subjects previously treated with systemic therapies to treat the cancer to be removed during this clinical investigation, such as neo-adjuvant chemotherapy or hormonal therapy.
Subjects undergoing breast conserving surgery whose resected specimen will be evaluated with frozen section.

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Lahey Hospital and Medical Center
Burlington, Massachusetts, 01805
Comprehensive Breast Care Center
Clearwater, Florida, 33756
Cleveland Clinic
Cleveland, Ohio, 44195
Dallas Breast Center
Dallas, Texas, 75231
Duke University Medical Center
Durham, North Carolina, 27710
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
MD Anderson Cancer Center
Houston, Texas, 77030
Baptist MD Anderson Cancer Physicians
Jacksonville, Florida, 32207
University of South Alabama
Mobile, Alabama, 36604
Yale University School of Medicine
New Haven, Connecticut, 06511
Stanford University Medical Center
Palo Alto, California, 94304
Beaumont Royal Oak
Royal Oak, Michigan, 48073
Franciscan Breast Surgery
Tacoma, Washington, 98405
Beaumont Troy
Troy, Michigan, 48098
Novant Health
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Feasibility Study Phase C: Expansion Into Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects With Breast Cancer

This is a non-randomized, open-label, multi-site study to collect safety and efficacy data on an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM imaging device), in identifying residual cancer in the tumor bed of female breast cancer patients. During the study, study physicians and clinical staff will complete hands-on training in anticipation of the upcoming pivotal study. Site-specific or user-specific issues related to the use of the device will be identified and addressed. Additionally, the data collected in the study will be used to continue training the tumor detection algorithm of the device.

In this study, patients will be injected with LUM015 prior to surgery. The study physicians will perform lumpectomy procedures according to his or her institution's standard of care practice. After the main specimen removal is completed, the study physician will use the LUM Imaging Device to image the tumor bed. Therapeutic shaves will be removed based on the recommendation of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.

Read the detailed description

For breast cancer lumpectomies, the presence of residual cancer cells left in the tumor bed after initial resection in inferred by post-operative margin assessment of the resected tissue by a pathologist.

Phase C enrollment will include approximately 5 patients per surgeon, with 2-3 surgeons per site and up to 20 sites. Subjects undergoing a lumpectomy procedure to treat primary breast cancer will be injected with a single dose of LUM015 4 ± 2 hours prior to surgery at a dose of 1.0 mg/kg. The sequence of events during the surgical procedure will vary based on the standard of care used by the surgeon. Patients will receive at a minimum the standard of care practices for each site. Lumicell-guided shaved cavity margins will be removed after the surgeon has attempted to remove the main specimen with grossly negative margins.

Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.

Conditions: Breast Cancer
Being tested: LUM Imaging System
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LUM Imaging SystemCombination product
Also called LUM015
Drug: LUM015 Device: LUM 2.6 Imaging Device

Study groups in NCT03321929
Study group	Role	What they receive
LUM Imaging System	Experimental	Single dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device Receives: Combination Product: LUM Imaging System

What is being measured

The primary outcome is the main question the study is designed to answer.

Collect Data to Refine and Verify the Tumor Detection Algorithm.
Data were collected from mITT population, which included all the patients imaged with the LUM Imaging System.
This metric measured the residual cancer that current Standard of Care (SOC) lumpectomy failed to remove.
It was defined as among all the patients, the percentage of subjects who had residual cancer found in at least one LUM-guided shave (therapeutic shave or "T-shave") after the current initial SOC lumpectomy procedure was completed.
Measured: 1 day

Secondary outcomes (8)

Number of Patients With Reported Adverse Events
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
Measured: Patients were evaluated for adverse events from time of injection until standard post-surgery follow-up visit (Median 31 days after lumpectomy).
Tumor Removal Rate in the Whole mITT Population by SOC Margin Status
Collect data to verify the detection algorithm reported in previous studies by SOC margin status
Measured: 1 week
Tumor Removal Rate Within Subjects Having Positive Standard of Care Margins
Tumor removal rate was measured as the percentage of the subjects who had residual tumor removed guided by Lumicell Imaging System after standard of care (SOC) procedure within subjects who had positive margins after SOC.
Measured: 1 Week
Tumor Removal Rate Within Subjects Having All Negative SOC Margins
Tumor removal rate was measured as the percentage of the subjects who had residual tumor removed guided by Lumicell Imaging System after standard of care (SOC) procedure within subjects who had negative margins after SOC.
Measured: 1 Week
Sensitivity and Specificity of the LUM Imaging System in Predicting Residual Cancer in the Cavity
Sensitivity and specificity were measured at the tissue level for the Lumicell imaging signal for the sensitivity and specificity on the residual tumor in the cavity of corresponding orientations after standard of care (SOC) of Lumpectomy. Generalized Estimating Equation (GEE) has been applied using generalized linear model having binomial link function and compound symmetry working correlation structure within each subject.
Measured: 1 Week
Detection and Conversion of Positive Margins in Subjects After BCS SOC
Conversion was measured as the ratio of the subjects having all the positive margins after BCS SOC converted to negatives after Lumicell Imaging guided procedure.
Detection was measured as the ratio of the subjects having all or at least one positive margin after BCS SOC detected by Lumicell Imaging System.
BCS: Breast-conserving surgery; SOC: Standard of Care
Measured: 1 Week
Volume of Therapeutic Shaves Removed During Lumpectomy.
The median volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured and the median total volume removed during lumpectomy was presented as well.
Measured: 1 Week
Contribution of Therapeutic Shaves to Total Volume Removed During Lumpectomy.
The contribution of the volumes of Lumicell Imaging System - guided shaves (therapeutic shaves) were measured as percentage of the sum of the volumes of the therapeutic shaves out of the total volume removed during lumpectomy.
Measured: 1 Week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Feb 201810 Apr 2020

First posted26 Oct 2017
Study start6 Feb 2018
Primary completion10 Apr 2020
Study completion10 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies 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: Interventional
Phase: Phase 2
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 234 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03321929
Sponsor's protocol ID: CL0006
Other IDs: 5R44CA211013-02
Status last verified: Jan 2023
First submitted: 13 Oct 2017
Last updated: 1 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: Yes
Individual data sharing: No

Publications

Hwang ES, Beitsch P, Blumencranz P, Carr D, Chagpar A, Clark L, Dekhne N, Dodge D, Dyess DL, Gold L, Grobmyer S, Hunt K, Karp S, Lesnikoski BA, Wapnir I, Smith BL; INSITE study team. Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence-Guided System: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Jul 1;157(7):573-580. doi: 10.1001/jamasurg.2022.1075.
PubMed 35544130

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study Phase C: Expansion Into Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects With Breast Cancer
ClinicalTrials.gov ID: NCT03321929
Acronym / sponsor ID: CL0006
Conditions: Breast Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 234 participants (actual)
Lead sponsor: Lumicell, Inc.Industry (pharma, biotech, devices)
Collaborators: National Cancer Institute (NCI)
Study start: 6 Feb 2018 (actual)
Primary completion: 10 Apr 2020 (actual)
Study completion: 10 Apr 2020 (actual)
First posted: 26 Oct 2017 (actual)
Results: Posted 1 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
LUM Imaging System	Experimental	Combination Product: LUM Imaging SystemSingle dose of LUM015 (1.0 mg/kg) will be administered by intravenous injection between 2 to 6 hours prior to surgery. All subjects undergo lumpectomy as standard of care and will have the study intervention, guidance by intraoperative imaging using the LUM Imaging Device

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or a combination of invasive breast cancer and DCIS. The protocol accepted methods for obtaining the histological samples are diagnostic core needle biopsies or fine needle biopsies.
Female, age of 18 years or older. Because no dosing or adverse event data are currently available on the use of LUM015 in subjects <18 years of age, children are excluded from this study.
Subjects must be scheduled for a lumpectomy for a breast malignancy.
Subjects must be able and willing to follow study procedures and instructions.
Subjects must have received and signed an informed consent form.

Key exclusion criteria (19 listed)

Subjects who are treated for bilateral breast cancer resection procedure.
Subjects who are pregnant at the time of diagnosis of their breast cancer; this exclusion is necessary because the teratogenic properties of LUM015 are unknown. Because there is an unknown but potential risk of adverse events in nursing infants secondary to treatment of the mother with LUM015, breastfeeding should be discontinued if the mother is treated with LUM015.
Subjects who are sexually active and not willing/able to use medically acceptable forms of contraception (hormonal or barrier method of birth control, abstinence) upon entering the study and for 60 days after injection of LUM015. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Breast cancer patients are routinely advised against becoming pregnant during treatment, so this requirement does not differ from standard of care.
Subjects who have taken an investigational drug within 30 days of enrollment.
Subjects with prolonged QTc interval defined as greater than 480 ms.

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
LUM Imaging SystemAlso: LUM015Drug: LUM015 Device: LUM 2.6 Imaging Device	Combination product	LUM Imaging System

Primary outcome

Collect Data to Refine and Verify the Tumor Detection Algorithm.
Time frame: 1 day
Data were collected from mITT population, which included all the patients imaged with the LUM Imaging System. This metric measured the residual cancer that current Standard of Care (SOC) lumpectomy failed to remove. It was defined as among all the patients, the percentage of subjects who had residual cancer found in at least one LUM-guided shave (therapeutic shave or "T-shave") after the current initial SOC lumpectomy procedure was completed.

8 secondary outcomes

Number of Patients With Reported Adverse Events
Time frame: Patients were evaluated for adverse events from time of injection until standard post-surgery follow-up visit (Median 31 days after lumpectomy).
Tumor Removal Rate in the Whole mITT Population by SOC Margin Status
Time frame: 1 week
Tumor Removal Rate Within Subjects Having Positive Standard of Care Margins
Time frame: 1 Week
Tumor Removal Rate Within Subjects Having All Negative SOC Margins
Time frame: 1 Week
Sensitivity and Specificity of the LUM Imaging System in Predicting Residual Cancer in the Cavity
Time frame: 1 Week
Detection and Conversion of Positive Margins in Subjects After BCS SOC
Time frame: 1 Week
Volume of Therapeutic Shaves Removed During Lumpectomy.
Time frame: 1 Week
Contribution of Therapeutic Shaves to Total Volume Removed During Lumpectomy.
Time frame: 1 Week

Results and safety

Results posted to the registry on 1 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
LUM Imaging System	234	230

Primary outcome: Collect Data to Refine and Verify the Tumor Detection Algorithm.

Time frame: 1 day. Number (95% Confidence Interval). Unit: Percentage

Measure	LUM Imaging System n = 230
Value	11.3 (7.5 to 16.1)

Population analysed: modified intent to treat population (mITT) includes subjects injected with LUM015 and LUM Imaging was performed

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events and adverse device effects, both serious and non-serious, and deaths that are encountered from initiation of study intervention, throughout the study, and within the first post-operative follow-up visit should be followed to their resolution, or until the principal investigator assesses them as stable, or the principal investigator determines the event to be irreversible, or the subject is lost to follow-up. Adverse events were assessed up to 30 days after enrollment.. Other adverse events reported at .9% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
LUM Imaging System	1 of 234 (0.4%)	215 of 234 (91.9%)	0 of 234

Limitations and caveats (from the sponsor): Protocol deviations may have impacted the reported performance. In some patients no LUM shaves were removed either because of protocol deviation or because the protocol limited the number of additional shaves that could be excised at any single margin. These deviations may have precluded full pathologic correlation and evaluation of clinical utility for many of the LUM images and may have prevented conversion of positive margins to negative margins.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35544130Hwang ES, Beitsch P, Blumencranz P, Carr D, Chagpar A, Clark L, Dekhne N, Dodge D, Dyess DL, Gold L, Grobmyer S, Hunt K, Karp S, Lesnikoski BA, Wapnir I, Smith BL; INSITE study team. Clinical Impact of Intraoperative Margin Assessment in Breast-Conserving Surgery With a Novel Pegulicianine Fluorescence-Guided System: A Nonrandomized Controlled Trial. JAMA Surg. 2022 Jul 1;157(7):573-580. doi: 10.1001/jamasurg.2022.1075.
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.

Barbara Smith, M.D., Ph.D. principal investigator

Massachusetts General Hospital

16 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LUM Imaging System in people with Breast Cancer, run by Lumicell, Inc. at 16 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 12 inclusion and 19 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 1 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 16 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Collect Data to Refine and Verify the Tumor Detection Algorithm. (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03321929, which also lists 1 linked publication.

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 1 May 2023.