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Laser Therapy
Novilase Laser Therapy for Breast Cancer
N/A
Recruiting
Led By John Lewin, MD
Research Sponsored by Novian Health Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Tumor is well visualized through ultrasound or x-ray mammography imaging and amenable to image-guidance therapy (i.e., a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins obscured by other structures or artifacts on the images)
Subject weight limited to ≤300 lbs. or ≤136 kg
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4-6 weeks
Awards & highlights
Study Summary
This trial will evaluate if Novilase can completely destroy malignant breast tumors in one procedure, compared to the standard of care, lumpectomy. Goal is 80% success rate, same as lumpectomy.
Who is the study for?
This trial is for women aged 18+ with breast tumors no larger than 15mm, visible on MRI or mammography, and at least 5mm from the skin/chest wall. Participants must not have severe chronic illnesses, be pregnant/breastfeeding, have certain allergies to contrast agents or metals, kidney disease, extensive intraductal components (>25%), or known BRCA positivity.Check my eligibility
What is being tested?
The Novilase Laser ablation technique is being tested for its ability to destroy malignant breast tumors up to 15mm in size. It's compared against lumpectomy standards aiming for less than a 20% retreatment rate. The procedure's success was previously indicated by a feasibility study.See study design
What are the potential side effects?
Potential side effects of Novilase Laser ablation may include discomfort at the treatment site, bruising or swelling post-procedure, changes in skin sensation near the treated area and risks associated with laser treatments such as burns.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My tumor can be clearly seen and distinguished from surrounding tissues on an ultrasound or mammogram.
Select...
I weigh 300 lbs (136 kg) or less.
Select...
My cancer is a single, small tumor not touching my skin or chest wall.
Select...
I don't have any major health issues besides my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4-6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4-6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery
Percentage of target tumors completely ablated in one procedure
Secondary outcome measures
Health related quality of life outcome measures at three timepoints via EORTC QLQ-C30 & QLQ-BR23 questionnaire (baseline and 4-6 weeks post-laser ablation and post-surgery)
Patient reported rate of return to activities of daily living post-laser ablation and post-surgery
Physician reported cosmetic satisfaction, utilizing the 4-point scoring system of breast cosmesis in protocol (e.g., excellent, good, fair, poor) post-laser ablation and post-surgery (4-6 weeks)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Novilase Laser Ablation and excisionExperimental Treatment1 Intervention
Eligible subject will receive image-guided laser ablation of a targeted malignant breast tumor. At 4-6 weeks following the ablation, she will receive a MRI and excision. Pathology and MRI will determine rate of complete ablation. Subject is expected to proceed with radiation and/or adjuvant therapy per standard of care.
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Who is running the clinical trial?
Novian Health Inc.Lead Sponsor
2 Previous Clinical Trials
168 Total Patients Enrolled
John Lewin, MDPrincipal InvestigatorYale University
Barbara Schwartzberg, MDPrincipal InvestigatorRose Medical Center
2 Previous Clinical Trials
168 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The tumor has no more than 10 mm of calcifications on imaging.My tumor is mostly non-invasive but has a tiny area that has started to spread.The tumor cannot be seen clearly on ultrasound or x-ray mammography images.The core biopsy shows that more than 25% of the lesion is an extensive intraductal component.I have tested positive for the BRCA gene mutation.You can join the study even if you have dense breast tissue on a mammogram, as long as there is a clear marker at the tumor site.The tumor has less than 25% of a specific type of tissue inside it, as determined by a core biopsy.My breast cancer is triple-negative.My tumor can be clearly seen and distinguished from surrounding tissues on an ultrasound or mammogram.I weigh 300 lbs (136 kg) or less.I agree to follow the treatment plan my doctor recommends.I cannot have gadolinium contrast due to a past allergic reaction or severe kidney issues.My tumor is larger than 15 mm in its biggest size.My tumor is not a common breast cancer type.I cannot lie on my stomach or back for an hour.I haven't had a definitive HER2 test as per medical guidelines.I am a woman aged 18 or older.My cancer is a single, small tumor not touching my skin or chest wall.I am under 18 years old.The tumor can be clearly seen on an MRI scan.The target tumor and its microcalcifications together are longer than 15 mm.I don't have any major health issues besides my cancer.You have a confirmed diagnosis through a needle core biopsy.My breast cancer is in an advanced stage.You cannot have an MRI due to having a pacemaker or certain metal implants, as per the site's rules.You have had severe asthma in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Novilase Laser Ablation and excision
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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 Canadian locations conducting this research project?
"The research protocol is currently running at 8 different medical locations, including New Haven, Bethesda and Cologne. To minimize travel needs for potential participants, it may be ideal to choose a site nearest you."
Answered by AI
Is enrollment for this experiment ongoing?
"As publicly available information from clinicaltrials.gov confirms, this medical study is presently not recruiting participants for the trial. This research was first posted on August 15th 2023 and its last update was made two weeks ago on August 2nd 2023. Despite that there are 4698 other studies who currently require patients to sign up right now."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
UC San Diego Health
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I have been researching about ablation and I may not be a candidate for breast surgery at this time.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
How long will the screenings take and when will the trial start?
PatientReceived 2+ prior treatments
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- UC San Diego Health: < 24 hours
Average response time
- < 1 Day
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