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Imaging Agent
Intraoperative Detection System for Breast Cancer
Phase 2
Waitlist Available
Led By Barbara Smith, MD, PhD
Research Sponsored by Lumicell, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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.
Subjects must have received neoadjuvant therapy for this breast cancer diagnosis prior to their lumpectomy procedure (cohorts 1 and 2).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
Study Summary
This trial is testing a new system to see if it helps doctors better treat breast cancer patients during surgery.
Who is the study for?
This trial is for women over 18 with confirmed invasive breast cancer or DCIS who are scheduled for a lumpectomy after neoadjuvant therapy. They must be able to follow the study, have signed consent, and not have serious medical issues. Exclusions include pregnancy, uncontrolled health problems like high blood pressure or infections, allergies to certain agents including PEG, recent investigational drugs use, HIV-positive on antiretrovirals, prior ipsilateral breast surgeries less than 2 years ago.Check my eligibility
What is being tested?
The LUM Imaging System is being tested in this study. It's used during breast conserving surgery to detect any residual cancer that might remain post-operation. The trial involves patients at multiple centers who are randomly assigned to receive this new imaging technology as part of their surgical treatment.See study design
What are the potential side effects?
Specific side effects related to the LUM Imaging System aren't detailed here but may include reactions similar to those from other contrast agents such as allergic reactions or discomfort at the injection site.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a type of breast cancer or DCIS.
Select...
I received treatment before my breast lump removal surgery.
Select...
I am scheduled for a lumpectomy due to breast cancer.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Development and validation of tumor detection algorithms in breast cancer patients receiving neoadjuvant therapy
Number of patients with reported adverse events
Reduction in residual tumor
+1 moreSide effects data
From 2022 Phase 3 trial • 406 Patients • NCT0368621591%
Chromaturia
6%
Seroma
6%
Breast pain
3%
Nausea
3%
Procedural pain
2%
Erythema
2%
Fatigue
1%
Constipation
1%
Blood creatinine decreased
1%
Ecchymosis
1%
Rash
1%
Pruritus
1%
Contusion
1%
Haematoma
100%
80%
60%
40%
20%
0%
Study treatment Arm
Device Intervention: LUM Imaging System Used During Surgery
Standard of Care Arm
Withdrawn Before Randomization
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Device Intervention: LUM Imaging System used during surgeryExperimental Treatment1 Intervention
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
Group II: Standard of Care ArmActive Control1 Intervention
The LUM Imaging Device will not be used to guide additional tissue removal. Patients in this arm will receive the study drug, LUM015.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Study Device Arm
2019
Completed Phase 3
~410
Find a Location
Who is running the clinical trial?
Lumicell, Inc.Lead Sponsor
8 Previous Clinical Trials
841 Total Patients Enrolled
3 Trials studying Breast Cancer
700 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,569 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,262 Patients Enrolled for Breast Cancer
Massachusetts General HospitalOTHER
2,928 Previous Clinical Trials
13,198,257 Total Patients Enrolled
80 Trials studying Breast Cancer
132,814 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I had a breast reduction on the same side less than 2 years ago.I am willing and able to follow the study's procedures and instructions.You have a low level of white blood cells.You have had an allergic reaction to polyethylene glycol (PEG) in the past.You have had an allergic reaction to any contrast agents given by mouth or through a vein.I am still experiencing side effects from previous medications or tests.Your platelet count is higher than 50,000 per microliter.I have cancer in both breasts and will have surgery to remove both.I am having surgery to remove a breast lump, and the tissue will be examined right away.Your liver enzyme levels are not more than 2.5 times the normal limit.I received treatment before my breast lump removal surgery.Your bilirubin levels are normal.I am not pregnant or breastfeeding if I am to be treated with LUM015.I have been diagnosed with a type of breast cancer or DCIS.I am scheduled for a lumpectomy due to breast cancer.I am a woman aged 18 or older.I don't have any serious health issues other than my cancer.I do not have any severe illnesses or mental health issues that would stop me from following the study's requirements.My blood pressure is controlled under medication.I have signed a consent form for this trial.I am not on HIV medication due to potential drug interactions.I am fully active or can carry out light work.Your kidney function is normal.You have had an allergic reaction to Tegaderm in the past.I have had surgery, mastectomy, reconstruction, or implants in the breast with cancer before.I had a breast biopsy on the same side less than 2 years ago.I will receive a dye for lymph node mapping before lumpectomy imaging.I am having a second lumpectomy due to cancer cells found at the edge of my first surgery's tissue.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there multiple establishments in the US currently conducting this research?
"10 clinical trial sites are now accepting patients for this medical study. Locations include Palo Alto, Durham, Winston-Salem and other cities across the US. To minimize travel costs, it would be prudent to select a site closest to you when enrolling in this study."
Answered by AI
Has the Study Device Arm been given regulatory clearance by the FDA?
"Despite lacking evidence to support its efficacy, our team at Power gauged the safety of Study Device Arm as a 2 due to preliminary supporting data."
Answered by AI
How many participants have signed up for this trial thus far?
"This trial necessitates the recruitment of 323 individuals who satisfy its criteria for participation. Stanford Hospital and Clinics in Palo Alto, California and Duke Cancer Center in Durham, North carolina are two of many medical sites facilitating this study's objectives."
Answered by AI
Is enrollment open for participants to join this research?
"According to the records on clinicaltrials.gov, this research is still open for enrollment having first been posted in September 2020 and last edited on August 15th 2022."
Answered by AI
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