NCT01478438

Brief Summary

This study will determine the rate of complete tumor ablation of small breast cancers (≤ 20mm) by Novilase Interstitial Laser Therapy (ILT), and determine the sensitivity and specificity of imaging (MRI, mammography and ultrasound) in detecting residual tumor post ILT ablation as correlated to histopathology from the post-ablation excision.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
2 countries

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 17, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 23, 2011

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
5.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2021

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

3.7 years

First QC Date

November 17, 2011

Last Update Submit

March 1, 2021

Conditions

Malignant Tumor

Keywords

Unifocal20mm in diametermeasures5mm away from the skin and chest

Outcome Measures

Primary Outcomes (1)

  • Collect information on the proportion of tumors ablated for sample size calculations in the pivotal trial

    Evaluate the rate of complete tumor ablation by Novilase ILT of small breast cancers and characterize the correlation of imaging (MR, US, x-ray) in detecting residual post ablation with histopathology of the excised specimen. An individual patient will be considered to have a complete ablation if the pathology results post excision demonstrates that no visible gross residual tumor is present.

    one month end point

Secondary Outcomes (1)

  • To gain experience with the cosmetic outcome and rate of recovery tools

    One month end point

Study Arms (1)

Treat and Excise

EXPERIMENTAL

All subjects will be treated with Interstitial Laser Therapy (ILT) followed by excision no later than 28 days post ablation.

Device: Novilase Interstitial Laser Therapy

Interventions

Novilase Interstitial Laser TherapyDEVICE

Image guided Interstitial Laser Ablation of breast tumors

Also known as: Novilase®
Treat and Excise

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Females 18 to 80 years of age
  • Tumor is well visualized through x-ray mammography or ultrasound imaging and amenable to image guidance therapy (a tumor which is well visualized through imaging can be identified from surrounding breast tissue and does not have margins
  • obscured by other structures or artifacts on the images)
  • Tumor must be well visualized (as defined above) on MRI
  • Definitive pathologic diagnosis by needle core biopsy
  • Unifocal malignant tumor that does not exceed 20mm in diameter and measures at least 5mm away from the skin and chest wall
  • Cluster of microcalcifications that do not exceed 10 mm in diameter and measures at least 5mm away from the skin and chest wall
  • Subjects with or without palpable lymph nodes
  • Subjects with mammographic appearance of overall dense parenchymal tissue may be included, as long as a clearly evident marker is present at tumor site
  • Subjects with less than 25% intraductal component
  • Subject has no clinically significant co-morbidities (i.e. chronic illnesses existing simultaneously with and usually independent of breast cancer) that affect life expectancy. Subject has given written informed consent
  • Subject agrees to comply with follow up visits

You may not qualify if:

  • Subjects younger than 18 years of age
  • Pregnant or breast-feeding women
  • Tumors poorly visualized by x-ray mammography or ultrasound imaging
  • Women who are morbidly obese (\>300 lbs)
  • Acute or chronic severe renal insufficiency (Glomerular filtration rate (GFR) \<30ml/min/1.73 sq.meters)
  • Moderate to end-stage kidney disease and a history of severe asthma or allergies
  • Tumors measuring greater than 20mm in diameter
  • Subjects with advanced stage breast cancer
  • Subjects with prior history of cancer in the ILT treated breast
  • Subjects with recurrent breast cancer
  • Subjects with lobular neoplasm, metastatic carcinoma to breast, sarcoma, Phylloides tumor, or Paget's disease
  • Subjects with benign vascular tumor
  • Subjects with benign lesions such as fibroadenoma, atypical ductal hyperplasia, sclerosing adenosis, Papilloma, fibrocystic disease of breast
  • Subjects with DCIS with microinvasion
  • Subjects with a cluster of microcalcifications whose diameter is larger than 10 mm.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

The Breast Center of Southern Arizona

Tucson, Arizona, 85712, United States

Location

Rose Medical Center - Rose Breast Center

Denver, Colorado, 80220, United States

Location

St. Alexius Breast Care of St. Alexius Medical Center

Bartlett, Illinois, 60103, United States

Location

Advocate Lutheran General Hospital - Caldwell Breast Center

Park Ridge, Illinois, 60068, United States

Location

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Columbia University Medical Center - Department of Surgery

New York, New York, 10032, United States

Location

University of Toledo - Eleanor N. Dana Cancer Center Breast Care

Toledo, Ohio, 43614, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73126, United States

Location

Wheaton Franciscan Health System

Wauwatosa, Wisconsin, 53226, United States

Location

North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre

Bristol, BS10 5NB, United Kingdom

Location

Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit

Chelmsford, CM1 7ET, United Kingdom

Location

Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital

Norwich, NR4 7UY, United Kingdom

Location

Related Publications (2)

  • Dowlatshahi K, Francescatti DS, Bloom KJ. Laser therapy for small breast cancers. Am J Surg. 2002 Oct;184(4):359-63. doi: 10.1016/s0002-9610(02)00942-x.

    PMID: 12383903BACKGROUND

  • Dowlatshahi K, Dieschbourg JJ, Bloom KJ. Laser therapy of breast cancer with 3-year follow-up. Breast J. 2004 May-Jun;10(3):240-3. doi: 10.1111/j.1075-122X.2004.21436.x.

    PMID: 15125752BACKGROUND

Related Links

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Barbara Schwartzberg, MD

    Rose Medical Center - Rose Breast Center

    PRINCIPAL INVESTIGATOR

  • Michael Shere, M.D.

    North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 17, 2011

First Posted

November 23, 2011

Study Start

April 1, 2012

Primary Completion

December 1, 2015

Study Completion

August 1, 2021

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations

US(9)GB(3)