Breast Cancer Trial, Recruiting NCT03463954 Sponsor: Novian Health Inc. Condition: Breast Cancer
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Breast Cancer Trial, Recruiting

NCT03463954
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Women aged 18 years and older
  • People who are able to give written consent on their own behalf
  • People who have had a needle core biopsy that confirmed a breast cancer diagnosis
  • People with a single breast tumor that is no larger than 15 mm at its widest point, and is either naturally located at least 5 mm away from the skin and chest wall, or can be moved that far away using a saline or local anaesthetic injection
  • People whose tumor has no more than 10 mm of calcium deposits, and those deposits are contained within the tumor itself
  • People whose tumor can be clearly seen on ultrasound or mammogram imaging, without the edges being hidden by surrounding tissue or image interference
  • People whose tumor is clearly visible on MRI
  • People with dense breast tissue on a mammogram may be considered, as long as a clear marker is visible at the tumor site
  • People whose tumor has less than 25% intraductal growth (a measure of how the cancer has spread within the breast ducts), as shown by core biopsy
  • People without serious ongoing illnesses that affect life expectancy
  • People who weigh 136 kg (300 lbs) or less
  • People who agree to follow their doctor's recommended radiation or additional drug therapy after the procedure

Who may not be able to join:

  • People under 18 years of age
  • People who are pregnant or breastfeeding
  • People whose tumor cannot be clearly seen on ultrasound or mammogram imaging
  • People who have had an allergic reaction to gadolinium-based contrast dye, or who have moderate to severe kidney disease (confirm specific kidney function threshold with trial site)
  • People who cannot have an MRI scan for any reason, such as having a pacemaker or certain metal implants (confirm with trial site)
  • People with a history of severe asthma
  • People whose tumor is larger than 15 mm at its widest point
  • People whose calcium deposits extend beyond the tumor, making the combined size larger than 15 mm
  • People with advanced-stage breast cancer
  • People whose tumor is a specific type not included in this trial, such as lobular neoplasm, cancer that has spread to the breast from elsewhere, sarcoma, Phyllodes tumor, or Paget's disease
  • People whose biopsy shows only a very early and limited form of cancer called DCIS with microinvasion
  • People whose tumor has more than 25% intraductal growth, as shown by core biopsy
  • People who are known to carry a BRCA gene mutation
  • People whose cancer tests negative for oestrogen receptors, progesterone receptors, and HER2 (known as triple-negative breast cancer)
  • People who are unable to lie flat on their front or back for one hour
  • People who are currently taking part in another clinical study involving a treatment, device, or drug that could interfere with this trial
  • People who have not had a HER2 test performed according to the relevant professional guidelines (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 14 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: John Lewin, MD, Yale University

Phone: 3122667200

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Novian Health Inc.
Registry
ClinicalTrials.gov
Start date
9 August 2023
Est. completion
31 December 2026

Where this trial is recruiting

🇩🇪 Germany 🇮🇱 Israel 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Percentage of target tumors completely ablated in one procedure; Frequency of adverse events (categorized using the NCI Common Terminology for Adverse Events (CTCAE) v4.0 guidelines) post-laser ablation and post-surgery

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 14 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov