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Procedure
Study Device Arm for Breast Cancer (INSITE Trial)
Phase 3
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1, during surgery
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing whether a new imaging system can help surgeons more accurately remove all cancerous tissue during breast surgery, in order to reduce the rates of positive margins.
Eligible Conditions
- Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1, during surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1, during surgery
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Patients Who Had Residual Cancer Found in at Least One LUM Imaging System Guided Shave Among All Patients.
Sensitivity of LUM Imaging System on Cancer in the Lumpectomy Cavity
Specificity of LUM Imaging System Detection on Cancer in the Lumpectomy Cavity
Secondary study objectives
Contribution of Therapeutic Shaves to Total Volume Removed During Lumpectomy.
Detection and Conversion of Positive Margins.
Removal of Residual Cancer Guided by the LUM Imaging System in Participants With Negative Margins After Standard-of-Care Surgery
+2 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%
Blood creatinine decreased
1%
Constipation
1%
Pruritus
1%
Rash
1%
Ecchymosis
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Withdrawn Before Randomization
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
533 Total Patients Enrolled
3 Trials studying Breast Cancer
392 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,906 Previous Clinical Trials
41,011,626 Total Patients Enrolled
941 Trials studying Breast Cancer
1,442,777 Patients Enrolled for Breast Cancer
Jorge Ferrer, PhDStudy DirectorLumicell, Inc.
1 Previous Clinical Trials
98 Total Patients Enrolled
1 Trials studying Breast Cancer
98 Patients Enrolled for Breast Cancer
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