RecruitingNAINTERVENTIONAL

Confirmatory Clinical Evaluation of Novilase® Laser Therapy for Focal Destruction of Malignant Breast Tumors

This study is investigating a new laser treatment called Novilase for destroying small breast cancer tumors, specifically those 15mm (about half an inch) or smaller. It's a key step to see if this laser method can become a standard option. Researchers want to know if Novilase can completely destroy these tumors in one go, similar to the success rate of traditional surgery, known as a lumpectomy. The main goal is to show that the laser treatment can fully remove the cancer in a large percentage of patients, ideally reducing the need for repeat surgeries. This could offer a less invasive way to treat certain breast cancers.

At a glance

Status

Recruiting

Phase

Sponsor

Novian Health Inc.

Enrolment target

122

Start

09 Aug 2023

Estimated completion

30 Mar 2027

Malignant Neoplasm of Breast

What is this study about?

This study is looking at a new treatment called Novilase laser therapy for women who have small breast cancers. These cancers need to be 15 millimetres (about half an inch) or less in size. The aim is to see if this laser treatment can completely destroy the cancer in the breast without needing traditional surgery like a lumpectomy, which removes the lump. We already know from an earlier study that this laser treatment was very successful in destroying almost all small tumours, so this study is a bigger, more formal test.

The main idea is to compare how well Novilase works against what's expected from a lumpectomy. For lumpectomies, doctors aim for a low rate of needing a second operation because some cancer cells were left behind. This study hopes to show that Novilase can achieve a similar high success rate in completely removing the cancer with just one treatment. If successful, this could mean a gentler, less invasive treatment option for some breast cancer patients.

Ultimately, if this study shows that Novilase is very effective at destroying these small breast cancers, it could become a new way to treat them. This could potentially reduce the number of surgeries some women need and offer a different choice for patients and their doctors.

Key takeaways

This study evaluates a laser treatment (Novilase) for small breast cancers.
It aims to offer a less invasive alternative to traditional surgery (lumpectomy).
Only small tumours (15mm or less) are eligible.
Participation involves laser treatment, MRI scans, and a follow-up surgery.
The study hopes to achieve a very high rate of complete cancer destruction.
Standard follow-up cancer treatments will still be prescribed by your doctor.

Who may be eligible?

This study is particularly for women who are 18 years old or older and have been diagnosed with a small breast cancer, specifically one that is 15mm or less in size. The cancer must be a single, isolated tumour, and it needs to be clearly visible on imaging tests like ultrasound, mammogram, and MRI, so the doctors can guide the laser therapy properly.

You cannot be pregnant or breastfeeding to join this study. Also, if you have certain medical conditions, especially problems with your kidneys or if you have metal implants in your body (like a pacemaker) that would prevent you from having an MRI scan, you wouldn't be able to take part. Your tumour also needs to be a certain distance from your skin and chest wall to be safely treated with the laser.

The doctors will also check if you have any other significant health problems that might affect your life expectancy. Your weight also needs to be 300 lbs (about 136 kg) or less. Essentially, they're looking for women with specific small breast cancers who are otherwise generally healthy enough to undergo the study procedures.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Do you have a breast cancer tumour that is 15mm or smaller?
Is your cancer a single spot, not spread out?
Are you able to have an MRI scan (e.g., no pacemaker, healthy kidneys)?
Are you NOT pregnant or breastfeeding?
Are you generally healthy, without other major health problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the first step is a screening MRI scan to ensure your tumour meets all the specific requirements. If you're eligible, you will then have the Novilase laser treatment. This procedure uses a laser to heat and destroy the cancer cells.

About 4 to 6 weeks after your laser treatment, you'll have another MRI scan to see how well the treatment worked. Following this, you will have a small operation (excision) to remove the area where the tumour was. This is done to check, under a microscope, if all the cancer cells were completely destroyed by the laser. After the study procedures, you will still follow your doctor's recommendations for any further standard treatments, like radiation or other therapies. The total duration of active participation in the study, from your laser treatment to the follow-up excision, will be about 4 to 6 weeks.

Potential risks and benefits

A potential benefit of joining this study is the chance to receive a less invasive treatment for your breast cancer, which might mean a quicker recovery compared to traditional surgery. However, as with any medical procedure, there are potential risks, such as bleeding, infection, or pain at the treatment site, or a chance that the laser treatment might not completely remove all the cancer cells, requiring further treatment. You are free to withdraw from the study at any time and for any reason, without it affecting your usual care.

Locations (13)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

City of Hope
Verified postcode
Duarte, United States· Withdrawn
UC San Diego Health
Verified postcode
La Jolla, United States· Recruiting
Eisenhower Health
Verified postcode
Rancho Mirage, United States· Recruiting
Yale University
Verified postcode
New Haven, United States· Recruiting
Walter Reed National Military Medical Center
Verified postcode
Bethesda, United States· Withdrawn
Summit Health
Verified postcode
Florham Park, United States· Not yet recruiting
Buffalo General Medical Center
Verified postcode
Buffalo, United States· Recruiting
St. Elisabeth-Krankenhaus Köln-Hohenlind
Verified postcode
Cologne, Germany· Recruiting
Ichilov | Tel Aviv Sourasky Medical Center
Verified postcode
Tel Aviv, Israel· Recruiting
Breast Centre Zurich
Verified postcode
Zurich, Switzerland· Terminated
University Hospital Zurich
Verified postcode
Zurich, Switzerland· Recruiting
Charing Cross Hospital, Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Novilase laser therapy?

Novilase is a special kind of laser treatment designed to heat and destroy small cancer tumours in the breast.

What's the main goal of this study?

The study aims to see if Novilase can completely destroy small breast cancers as effectively as traditional surgery, potentially reducing the need for second operations.

Are there any size limits for the cancer?

Yes, this study is specifically for breast cancers that are 15 millimetres (about half an inch) or smaller.

Will I still need other treatments if I join?

Yes, after the study procedures, you will continue with any standard treatments like radiation or other therapies your doctor recommends.

Can I participate if I'm pregnant?

No, women who are pregnant or breastfeeding cannot join this study.

How to find out more

Eugene Bajorinas

ebajorinas@novianhealth.com 3122667200 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.