Breast CancerPhase 2NCT04440982
Feasibility Study of Intraoperative Detection of Residual Cancer in Breast Cancer Patients
A Phase 2 study testing LUM015 and Lum Imaging System in people with Breast Cancer and Neoadjuvant Therapy, run by Lumicell, Inc. at 6 sites in United States.
Trial summary
This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Neoadjuvant Therapy
- What is being tested?
- LUM015 and Lum Imaging System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 6 sitesUnited States
- Study dates
- 1 Sep 2020to 29 Feb 2024
- Phase
- Phase 2
- 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
Who may be able to join
- Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component.
- Female, age of 18 years or older.
- Subjects must have received neoadjuvant therapy for this breast cancer diagnosis prior to their lumpectomy procedure (cohorts 1 and 2).
- 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.
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- Subjects must have no uncontrolled serious medical problems except for the diagnosis of cancer, as per the exclusion criteria listed below.
- Leukocytes > 1,000/mcL
- Platelets > 50,000/mcL
- total bilirubin within normal institutional limits
- AST (SGOT)/ALT (SGPT) < 2.5 X institutional upper limit of normal
- eGFR >= 60mL/min/1.73m2
- Subjects with ECOG performance status of 0 or 1.
Who cannot join
- Subjects who have been diagnosed with bilateral breast cancer and are undergoing bilateral resection procedure.
- Subjects who are pregnant at the time of diagnosis of their breast cancer. 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.
- Subjects who have taken an investigational drug within 14 days of enrollment.
- Subjects who will have administration of methylene blue or any blue or green dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.
- Subjects who have not recovered from adverse events due to other pharmaceutical or diagnostic agents.
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- 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.
- Subjects with a history of allergic reaction to polyethylene glycol (PEG).
- Subjects with a 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 undergoing breast conserving surgery whose resected specimen (main lump, shaves, or any other resected tissue) will be evaluated with frozen section after the Lumicell-guided removal of shaves.
- Subjects with a history of allergic reaction to Tegaderm
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Morton Plant Mease Health Care Oncology Research
Clearwater, Florida, 33756
Duke Cancer Center
Durham, North Carolina, 27710
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Stanford Hospital and Clinics
Palo Alto, California, 94304
Novant Health Cancer Center
Winston-Salem, North Carolina, 27103
About this study
Official title: Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Breast Cancer Patients Receiving and Not Receiving Neoadjuvant Therapy
This is a prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.
Read the detailed description
Detailed Description:
All subjects will be injected with LUM015. The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg. For all subjects, surgeons will perform main specimen resection per standard of care. For subjects randomized to the intervention arm, the surgeon will use the Lum System to scan and image all orientations within the cavity and The LUM Imaging System will guide shave removal. Then, for all subjects (control and intervention arm), comprehensive shaved margins are removed.
In this study, the initial cohort is a "training set" with 10 patients receiving neoadjuvant therapy to refine the tumor detection algorithm, if needed. After completion of enrollment of the initial 10 subjects for algorithm training, the Investigators will then enroll a cohort of patients who received neoadjuvant therapy to further evaluate the performance of the LUM Imaging System in this important subset of breast cancer patients. Concurrently to the enrollment of this cohort, surgeons will also enroll a cohort of patients who did not receive neoadjuvant therapy prior to surgery. Patients will be randomized 3:1 to a LUM-assisted lumpectomy versus a standard lumpectomy. In both arms, shaved margins will be taken from the entire lumpectomy cavity to compare the extent of residual tumor after standard and LUM-assisted lumpectomies to evaluate the negative predictive value of the LUM Imaging System following neoadjuvant therapy. Only the group of patients randomized to the device (intervention) arm will have the LUM Imaging System guide the removal of tissue prior to the removal of final comprehensive shaves of the entire cavity.
Study treatment ends when the surgery is completed. Patients are followed for adverse events until their standard of care follow-up visit or after any secondary surgery, whichever is longer.
- Conditions
- Breast Cancer, Neoadjuvant Therapy
- Being tested
- LUM015, Lum Imaging System
- Keywords
- breast cancer surgery, lumpectomy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LUM015Drug
LUM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm.
Lum Imaging SystemDevice
UM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm.
| Study group | Role | What they receive |
|---|---|---|
| Device Intervention: LUM Imaging System used during surgery | Experimental | The LUM Imaging Device will be used to look inside the lumpectomy cavity to see if the dye indicates any areas that may contain residual tumor. If the imaging identifies that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an additional piece of tissue. This process will be continued until a negative reading from the device is obtained or a maximum of 2 shaves of additional tissue has been removed. Patients in this arm will receive the study drug, LUM015 Receives: Drug: LUM015; Device: Lum Imaging System |
| Standard of Care Arm | Other | The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015. Receives: Drug: LUM015 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development and validation of tumor detection algorithms in breast cancer patients receiving neoadjuvant therapy
Refining of the previously validated tumor detection algorithm in breast cancer patients receiving neoadjuvant therapy will be conducted in the first cohort and the validation of this algorithm will use data from the second cohort.
Measured: 1 month
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: 14 days
Reduction in residual tumor
Evaluate reduction in residual tumor left after Lumicell assisted lumpectomy compared with SoC removal of main lumpectomy specimen in patients who have received and not received neo-adjuvant therapy
Measured: 3 months
Report on patient reported outcomes and patient preference information
Collect and summarize patient reported information on outcomes and preference
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2020
- Study start1 Sep 2020
- Primary completion30 Nov 2023
- Study completion29 Feb 2024
Why it stopped: Required resources unavailable.
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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to receive the device intervention. All subjects will receive the study drug.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lumicell, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Barbara Smith, MD, PhD, Principal investigator, Massachusetts General HospitalJorge Ferrer, PhD, Study director, Lumicell, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04440982
- Sponsor's protocol ID
- CLP0008
- Other IDs
- 1R01CA212138-01
- Status last verified
- Jan 2025
- First submitted
- 12 Jun 2020
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Evaluate Performance of the LUM Imaging System for Intraoperative Detection of Residual Tumor in Breast Cancer Patients Receiving and Not Receiving Neoadjuvant Therapy
- ClinicalTrials.gov ID
- NCT04440982
- Acronym / sponsor ID
- CLP0008
- Conditions
- Breast Cancer, Neoadjuvant Therapy
- Keywords
- breast cancer surgery, lumpectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Required resources unavailable.
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Lumicell, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 22 Jun 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 prospective, multi-center, randomized, clinical trial evaluating patients undergoing breast conserving surgery using the LUM Imaging System.
Detailed description
Detailed Description:
All subjects will be injected with LUM015. The injection of the study drug will occur 2-6 hours prior to surgery at a dose of 1.0 mg/kg. For all subjects, surgeons will perform main specimen resection per standard of care. For subjects randomized to the intervention arm, the surgeon will use the Lum System to scan and image all orientations within the cavity and The LUM Imaging System will guide shave removal. Then, for all subjects (control and intervention arm), comprehensive shaved margins are removed.
In this study, the initial cohort is a "training set" with 10 patients receiving neoadjuvant therapy to refine the tumor detection algorithm, if needed. After completion of enrollment of the initial 10 subjects for algorithm training, the Investigators will then enroll a cohort of patients who received neoadjuvant therapy to further evaluate the performance of the LUM Imaging System in this important subset of breast cancer patients. Concurrently to the enrollment of this cohort, surgeons will also enroll a cohort of patients who did not receive neoadjuvant therapy prior to surgery. Patients will be randomized 3:1 to a LUM-assisted lumpectomy versus a standard lumpectomy. In both arms, shaved margins will be taken from the entire lumpectomy cavity to compare the extent of residual tumor after standard and LUM-assisted lumpectomies to evaluate the negative predictive value of the LUM Imaging System following neoadjuvant therapy. Only the group of patients randomized to the device (intervention) arm will have the LUM Imaging System guide the removal of tissue prior to the removal of final comprehensive shaves of the entire cavity.
Study treatment ends when the surgery is completed. Patients are followed for adverse events until their standard of care follow-up visit or after any secondary surgery, whichever is longer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomized to receive the device intervention. All subjects will receive the study drug.
| Arm | Type | Receives |
|---|---|---|
| Device Intervention: LUM Imaging System used during surgery | Experimental | Drug: LUM015, Device: Lum Imaging SystemThe LUM Imaging Device will be used to look inside the lumpectomy cavity to see if the dye indicates any areas that may contain residual tumor. If the imaging identifies that there may be cancer cells remaining in the lumpectomy cavity, the surgeon will remove an additional piece of tissue. This process will be continued until a negative reading from the device is obtained or a maximum of 2 shaves of additional tissue has been removed. Patients in this arm will receive the study drug, LUM015 |
| Standard of Care Arm | Other | Drug: LUM015The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subjects must have histologically or cytologically confirmed primary invasive breast cancer, ductal carcinoma in situ (DCIS) or primary invasive breast cancer with a DCIS component.
- Female, age of 18 years or older.
- Subjects must have received neoadjuvant therapy for this breast cancer diagnosis prior to their lumpectomy procedure (cohorts 1 and 2).
- Subjects must be scheduled for a lumpectomy for a breast malignancy.
- Subjects must be able and willing to follow study procedures and instructions.
Key exclusion criteria (18 listed)
- Subjects who have been diagnosed with bilateral breast cancer and are undergoing bilateral resection procedure.
- Subjects who are pregnant at the time of diagnosis of their breast cancer. 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.
- Subjects who have taken an investigational drug within 14 days of enrollment.
- Subjects who will have administration of methylene blue or any blue or green dye for sentinel lymph node mapping on the day of the surgery prior to imaging the lumpectomy cavity with the LUM Imaging Device.
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 |
|---|---|---|
| LUM015LUM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm. | Drug | Device Intervention: LUM Imaging System used during surgery, Standard of Care Arm |
| Lum Imaging SystemUM015 will be administered 2 to 6 hours prior to surgery for both arms. The LUM Imaging device will be used to assist in the removal of additional tumor tissue in the device intervention arm. | Device | Device Intervention: LUM Imaging System used during surgery |
Primary outcome
Development and validation of tumor detection algorithms in breast cancer patients receiving neoadjuvant therapy
Time frame: 1 month
Refining of the previously validated tumor detection algorithm in breast cancer patients receiving neoadjuvant therapy will be conducted in the first cohort and the validation of this algorithm will use data from the second cohort.
Number of patients with reported adverse events
Time frame: 14 days
Reported adverse events will be assessed and aggregated according to event type, relation to device or drug, and severity.
Reduction in residual tumor
Time frame: 3 months
Evaluate reduction in residual tumor left after Lumicell assisted lumpectomy compared with SoC removal of main lumpectomy specimen in patients who have received and not received neo-adjuvant therapy
Report on patient reported outcomes and patient preference information
Time frame: 12 months
Collect and summarize patient reported information on outcomes and preference
Results and safety
The study was stopped early (reason given: Required resources unavailable.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- 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, MD, PhD principal investigator
Massachusetts General Hospital
Jorge Ferrer, PhD study director
Lumicell, Inc.
6 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 LUM015 and Lum Imaging System in people with Breast Cancer and Neoadjuvant Therapy, run by Lumicell, Inc. at 6 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 13 inclusion and 18 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: stopped early, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
The study was stopped early (reason given: Required resources unavailable.). 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?
Development and validation of tumor detection algorithms in breast cancer patients receiving neoadjuvant therapy (time frame: 1 month). The study lists 4 primary outcomes in all. 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 15 Jan 2025.