Novilase Laser Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen by John Lewin, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Novian Health Inc.

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

No Placebo Group

Approved in 3 Jurisdictions

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}

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.

Trial 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 (Laser Therapy)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Yale University New Haven, CT

Summit Health Florham Park, NJ

Buffalo General Medical Center Buffalo, NY

Walter Reed National Military Medical Center Bethesda, MD

More Trial Locations

Who Is Running the Clinical Trial?

Novian Health Inc. Lead Sponsor

References

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

Long-term Follow-up After Interstitial Laser Thermotherapy of Breast Cancer. [2015] To review the effect of immunological changes induced by interstitial laser thermotherapy (ILT) on long-term outcome of patients with breast cancer.

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

Applications of laser technology in breast cancer therapy. [2019] Breast cancer is an increasingly common problem affecting one in nine women. The optimal management of carcinoma of the breast remains controversial. This paper reviews the rationale for the use of laser technology in the treatment of primary and advanced breast cancer. The CO2 laser has several properties which make it advantageous for breast surgery. The technical details for optimal laser utilization are presented. Experimental evidence documents a marked reduction of local tumor recurrence following surgery with lasers. Preliminary human studies suggest that laser use lengthens the disease-free interval and may decrease local recurrence. Interstitial laser therapy holds promise for use in the treatment of locally advanced breast tumors and has been suggested by some as a potential modality for the primary therapy of breast cancer. The clinical use of lasers in the treatment of breast cancer is justified.

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

Interstitial laser hyperthermia model development for minimally invasive therapy of breast carcinoma. [2019] This investigation describes the preclinical development of a laser fiberoptic interstitial delivery system for the thermal destruction of small breast cancers. We propose adaptation of this technology to stereotactic mammographic instrumentation currently employed for diagnostic core biopsy to thermally ablate a site of disease with maximal treatment efficacy, minimal observable superficial change, reduced patient trauma, and lowered overall treatment costs.

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

Interstitial laser photocoagulation as a treatment for breast cancer. [2019] This preliminary report describes the use of interstitial laser photocoagulation to manage small breast cancers. Forty-four patients were treated with a diode laser of 805 nm under local anaesthesia in the interval between diagnosis and surgery. Ultrasonography was used in 42 patients and computed tomography (CT) in two to place the fibre in the tumour and monitor laser effects. Laser-induced necrosis within the resected tumour varied from 0 to 25 mm in diameter. The presence of charring in the tumour around the fibre tip after treatment was associated with significantly larger diameters of necrosis than when charring did not occur (median 13 versus 6 mm, P = 0.002). Precharring the fibre resulted in a more predictable diameter of necrosis (median 14 mm). Ultrasonography was inaccurate in assessing laser damage; dynamic CT and magnetic resonance imaging may be of more use. Interstitial laser photocoagulation is simple and safe, and can produce necrosis of a reasonably predictable extent.

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

Nd: YAG interstitial laser thermotherapy in the treatment of breast cancer. [2019] "Minimal treatment strategy" is desirable in certain breast cancer patients. The main objective of the present study is to examine the use of interstitial laser thermotherapy (laserthermia) for this purpose.

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] Laser interstitial thermal therapy has been used as an ablative treatment for glioma; however, its development was limited due to technical issues. The NeuroBlate System incorporates several technological advances to overcome these drawbacks. The authors report a Phase I, thermal dose-escalation trial assessing the safety and efficacy of NeuroBlate in recurrent glioblastoma multiforme (rGBM).

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

[CO2 lasers in the treatment of breast cancer]. [2007] The paper is a review of the experience gained by foreign and Soviet (the Moscow Cancer Research Institute) investigators in using high-energy CO2-laser fo treatment of breast cancer. It is demonstrated that employment of laser scalpel improves operative results, does not induce complications, prolongs survival and recurrence-free period of breast cancer patients.