Novilase Laser Therapy for Breast Cancer

Recruiting at 10 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

Trial Summary

What is the purpose of this trial?

This trial is testing a laser treatment called Novilase to destroy small breast cancer tumors. It targets patients with tumors 15 mm or smaller, aiming to offer a less invasive option than surgery. The laser works by heating and killing the cancer cells.

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 data supports the effectiveness of the Novilase treatment for breast cancer?

Research shows that using lasers in breast cancer treatment can reduce the chance of the cancer coming back after surgery and may help patients stay cancer-free longer. Interstitial laser therapy, which involves placing a laser directly into the tumor, has been shown to effectively destroy small breast cancers with minimal side effects. ^{1 2 3 4 5}

How is Novilase Laser Therapy different from other breast cancer treatments?

Novilase Laser Therapy is unique because it uses a laser to destroy small breast tumors from the inside, which can reduce patient trauma and treatment costs compared to traditional surgery. This minimally invasive approach aims to effectively target the tumor with minimal visible changes to the breast. ^{2 3 4 6 7}

Research Team

John Lewin, MD

Principal Investigator

Yale University

Eligibility Criteria

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

The tumor cannot be seen clearly on ultrasound or x-ray mammography images.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

References

1. Greece pubmed.ncbi.nlm.nih.gov

Long-term Follow-up After Interstitial Laser Thermotherapy of Breast Cancer. [2015]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. United States pubmed.ncbi.nlm.nih.gov

Interstitial laser hyperthermia model development for minimally invasive therapy of breast carcinoma. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Interstitial laser photocoagulation as a treatment for breast cancer. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Nd: YAG interstitial laser thermotherapy in the treatment of breast cancer. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Results of the NeuroBlate System first-in-humans Phase I clinical trial for recurrent glioblastoma: clinical article. [2022]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[CO2 lasers in the treatment of breast cancer]. [2007]