Novilase Laser Therapy for Breast Cancer

Recruiting at 8 trial locations

Overseen By Mohammad Eghtedari, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Novian Health Inc.

Disqualifiers: Pregnant, Breast-feeding, Severe asthma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 1 day

122 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a laser therapy called Novilase for treating small breast cancer tumors (15 mm or less). The goal is to determine if this laser treatment can effectively destroy tumors without requiring surgery, such as a lumpectomy. Participants will undergo the laser therapy, followed by a follow-up MRI and tumor removal to assess the treatment's effectiveness. Women with a breast cancer tumor that meets specific size and location criteria and is visible through imaging may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options without the constraints of traditional phase requirements.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must agree to comply with standard radiation or additional therapy as prescribed by your doctor.

What prior data suggests that Novilase Laser Therapy is safe for breast cancer treatment?

Research has shown that Novilase laser therapy is generally well-tolerated for treating small breast tumors. In earlier studies, patients with breast tumors 15mm or smaller achieved a 98% success rate in completely removing the tumor with just one treatment. This indicates that the procedure was effective in nearly all cases without requiring a second treatment.

While the focus is on its effectiveness, safety is also a priority. Because this procedure is less invasive than traditional surgery, it may result in fewer side effects. This laser therapy offers an alternative to standard surgery, potentially leading to less pain and a quicker recovery.

Although specific safety data is limited, the therapy's success and less invasive nature suggest it is likely safe. For those considering joining a trial, this history of safety and effectiveness may provide reassurance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Novilase Laser Therapy is unique because it employs a minimally invasive laser ablation technique to target and destroy malignant breast tumors. Unlike traditional breast cancer treatments like surgery, chemotherapy, or radiation, Novilase uses laser energy to precisely ablate the tumor, which may preserve more healthy tissue and potentially reduce recovery time. Researchers are excited about this treatment because it offers a targeted, image-guided approach, allowing for more precise treatment of tumors and potentially improving patient outcomes with fewer side effects.

What evidence suggests that Novilase might be an effective treatment for breast cancer?

Studies have shown that Novilase, a type of laser therapy, holds promise for treating small breast tumors. One study showed that 98% of tumors 15 mm or smaller were completely destroyed in just one session. Another study found that Novilase effectively removed early-stage breast cancers up to 15 mm in size. In this trial, participants will receive Novilase Laser Ablation followed by excision to determine the rate of complete ablation. The goal is to achieve a complete tumor destruction rate higher than 87.85%, the standard for success. These findings suggest that Novilase could serve as a strong alternative to traditional surgery, like lumpectomy, for small breast tumors. ^{1 3 4 5 6}

Who Is on the Research Team?

John Lewin, MD

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

The tumor has no more than 10 mm of calcifications on imaging.

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.

Exclusion Criteria

My tumor is mostly non-invasive but has a tiny area that has started to spread.

Pregnant or breast-feeding

Subject who is currently participating in another investigational treatment, device or drug study through follow up that would interfere with this trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive image-guided laser ablation of a targeted malignant breast tumor

1 day

1 visit (in-person)

Follow-up

Participants undergo MRI and excision to determine rate of complete ablation

4-6 weeks

1 visit (in-person)

Post-treatment

Participants are expected to proceed with radiation and/or adjuvant therapy per standard of care

What Are the Treatments Tested in This Trial?

Interventions

• Novilase

Trial Overview 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.

How Is the Trial Designed?

Group I: Novilase Laser Ablation and excision Experimental Treatment 1 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.

Novilase is already approved in European Union, Switzerland, United States for the following indications:

Approved in European Union as Novilase for:

• Malignant breast tumors
• Benign breast tumors (fibroadenomas)

Approved in Switzerland as Novilase for:

• Malignant breast tumors
• Benign breast tumors (fibroadenomas)

Approved in United States as Novilase for:

• Benign breast tumors (fibroadenomas)
• Soft tissue ablation

Who Is Running the Clinical Trial?

Novian Health Inc.

Lead Sponsor

Trials

3

Recruited

290+

Published Research Related to This Trial

Interstitial laser photocoagulation is a safe and effective method for managing small breast cancers, as demonstrated in a preliminary study involving 44 patients.

The treatment can create a predictable area of necrosis in tumors, with larger necrosis associated with charring at the fiber tip, indicating that precharring the fiber can enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interstitial laser photocoagulation as a treatment for breast cancer. Harries, SA., Amin, Z., Smith, ME., et al.[2019]

The study developed a laser fiberoptic system for targeted thermal destruction of small breast cancers, demonstrating effective localized heating in both ex vivo human and porcine tissues, which could minimize damage to surrounding areas.

In vivo tests showed that the Nd:YAG laser could create a defined volume of tissue necrosis without harming adjacent tissues or skin, suggesting a promising minimally invasive treatment option for small breast tumors detected through mammography.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interstitial laser hyperthermia model development for minimally invasive therapy of breast carcinoma. Robinson, DS., Parel, JM., Denham, DB., et al.[2019]

The use of high-energy CO2 lasers as a surgical tool for breast cancer treatment has shown to improve surgical outcomes without causing complications.

Patients treated with laser scalpels experienced longer survival rates and extended periods without cancer recurrence, indicating the efficacy of this method in breast cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[CO2 lasers in the treatment of breast cancer]. Demidov, VP., Putyrskiĭ, LA.[2007]

Laser technology, particularly CO2 lasers, shows promise in breast cancer treatment by reducing local tumor recurrence after surgery, based on experimental evidence.

Preliminary human studies indicate that laser treatment may extend the disease-free interval and decrease local recurrence rates, suggesting its potential as a primary therapy for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of laser technology in breast cancer therapy. Lanzafame, RJ.[2019]

Interstitial laser thermotherapy (ILT) increased the presence of cytotoxic T lymphocytes and mature dendritic cells in breast cancer patients, while reducing regulatory T cells, indicating a potential immune response enhancement.

Despite these immune changes, ILT did not correlate with improved long-term prognosis, and the treatment showed no adverse effects over a follow-up period of 116 months, suggesting it is a safe option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Follow-up After Interstitial Laser Thermotherapy of Breast Cancer. Haraldsdóttir, KH., Ingvar, C., Stenram, U., et al.[2015]

The NeuroBlate System, a new technology for laser interstitial thermal therapy, was assessed in a Phase I trial involving 10 patients with recurrent glioblastoma multiforme, demonstrating controlled thermal ablation and a median survival of 316 days.

While treatment-related edema occurred in most patients and three experienced Grade 3 adverse events, the therapy showed potential efficacy with neurological improvement in three patients and a high percentage of tumor treated (78% on average).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma: clinical article. Sloan, AE., Ahluwalia, MS., Valerio-Pascua, J., et al.[2022]

In a study of 35 breast cancer patients, interstitial laser thermotherapy (laserthermia) demonstrated the potential for local tumor control, achieving disease-free survival in 5 out of 7 patients who received it as the only treatment.

The results indicated that while laserthermia can effectively treat small tumors, it may not be suitable for premenopausal patients, as evidenced by a significantly lower 3-year disease-free survival rate compared to menopausal patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nd: YAG interstitial laser thermotherapy in the treatment of breast cancer. Akimov, AB., Seregin, VE., Rusanov, KV., et al.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01478438

A Multicenter "Ablate and Resect" Study of Novilase ... This study will determine the rate of complete tumor ablation of small breast cancers (≤ 20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the ...

2. novilase.com novilase.com/breast-cancer/br-003

BR-003 Clinical Trial The main goal of the BR-003 clinical trial is to evaluate the effectiveness of tumor ablation for early-stage breast cancers that are 15 mm or smaller in size.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6208881/

Phase 2 Open-Label Trial Investigating Percutaneous Laser ... An institutional review board-approved, multicenter clinical trial was designed to determine the efficacy and outcome of percutaneous laser ablation (PLA) ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03463954

Study Details | NCT03463954 | Confirmatory ... Specifically, Novilase will have demonstrated success if the complete tumor ablation rate is greater than 87.85%. Official Title. Prospective, Multicenter ...

5. novilase.com novilase.com/breast-cancer/laserbreast1

Previous study: LaserBreast1 Clinical Trial LASERBREAST1: Local treatment by interstitial laser thermal destruction of primary breast cancer (≤20 mm). The purpose of the LASERBREAST1 clinical trial:.

6. novilase.com novilase.com/medical-professionals

Medical Professionals Novilase Breast Therapy provides patients with both malignant and benign breast tumors a less invasive alternative to traditional surgery, offering numerous ...