Malignant TumorNCT01478438
A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
A study testing Novilase Interstitial Laser Therapy in people with Malignant Tumor, run by Novian Health Inc. at 12 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Malignant Tumor
- What is being tested?
- Novilase Interstitial Laser Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 12 sitesin 2 countries
- Study dates
- Apr 2012to Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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.
- Subjects with extensive intraductal component and other characteristics not well visualized by imaging studies
- Subjects who are BRCA positive.
- Inability to lie prone or supine for one hour
- Currently participating or enrolled in another investigational treatment, device or drug study through follow up
- Undergoing concurrent neoadjuvant therapies for breast cancer
- Cardiac pacemaker or other metallic implants which would prevent patient from safely undergoing MRI scan
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States9 sites
St. Alexius Breast Care of St. Alexius Medical Center
Bartlett, Illinois, 60103
Walter Reed National Military Medical Center
Bethesda, Maryland, 20889
Rose Medical Center - Rose Breast Center
Denver, Colorado, 80220
Columbia University Medical Center - Department of Surgery
New York, New York, 10032
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73126
Advocate Lutheran General Hospital - Caldwell Breast Center
Park Ridge, Illinois, 60068
University of Toledo - Eleanor N. Dana Cancer Center Breast Care
Toledo, Ohio, 43614
The Breast Center of Southern Arizona
Tucson, Arizona, 85712
Wheaton Franciscan Health System
Wauwatosa, Wisconsin, 53226
United Kingdom3 sites
North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
Bristol, BS10 5NB
Mid Essex Hospital Services NHS Trust: Broomfield Hospital - Breast Unit
Chelmsford, CM1 7ET
Norfolk & Norwich University NHS Foundation Trusts: Norfolk and Norwich University Hospital
Norwich, NR4 7UY
About this study
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.
- Conditions
- Malignant Tumor
- Being tested
- Novilase Interstitial Laser Therapy
- Keywords
- Unifocal, 20mm in diameter, measures, 5mm away from the skin and chest
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novilase Interstitial Laser TherapyDevice
Also called Novilase®
Image guided Interstitial Laser Ablation of breast tumors
| Study group | Role | What they receive |
|---|---|---|
| Treat and Excise | Experimental | All subjects will be treated with Interstitial Laser Therapy (ILT) followed by excision no later than 28 days post ablation. Receives: Device: Novilase Interstitial Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month end point
Secondary outcomes (1)
To gain experience with the cosmetic outcome and rate of recovery tools
Evaluate satisfaction, utilizing the European Organization for Research and Treatment of Cancer Breast Cancer Specific Quality of Life Questionnaire (EORTC QLQ-BR23) survey and cosmetic outcome utilizing the physician-reported Four-Point Scoring System of Breast Cosmesis.
Measured: One month end point
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startApr 2012
- Primary completionDec 2015
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novian Health Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Schwartzberg, MD, Principal investigator, Rose Medical Center - Rose Breast CenterMichael Shere, M.D., Principal investigator, North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478438
- Sponsor's protocol ID
- BR-002
- Status last verified
- Mar 2021
- First submitted
- 17 Nov 2011
- Last updated
- 3 Mar 2021
- Results posted
- No
Publications
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.
PubMed 12383903Dowlatshahi 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.
PubMed 15125752
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter "Ablate and Resect" Study of Novilase® Interstitial Laser Therapy for the Ablation of Small Breast Cancers
- ClinicalTrials.gov ID
- NCT01478438
- Acronym / sponsor ID
- BR-002
- Conditions
- Malignant Tumor
- Keywords
- Unifocal, 20mm in diameter, measures, 5mm away from the skin and chest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Novian Health Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Aug 2021 (estimated)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treat and Excise | Experimental | Device: Novilase Interstitial Laser TherapyAll subjects will be treated with Interstitial Laser Therapy (ILT) followed by excision no later than 28 days post ablation. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novilase Interstitial Laser TherapyAlso: Novilase®Image guided Interstitial Laser Ablation of breast tumors | Device | Treat and Excise |
Primary outcome
Collect information on the proportion of tumors ablated for sample size calculations in the pivotal trial
Time frame: one month end point
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.
1 secondary outcome
To gain experience with the cosmetic outcome and rate of recovery tools
Time frame: One month end point
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Background: PubMed 12383903Dowlatshahi 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.
- Background: PubMed 15125752Dowlatshahi 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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Schwartzberg, MD principal investigator
Rose Medical Center - Rose Breast Center
Michael Shere, M.D. principal investigator
North Bristol NHS Trust: Southmead Hospital - The Breast Care Centre
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novilase Interstitial Laser Therapy in people with Malignant Tumor, run by Novian Health Inc. at 12 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect information on the proportion of tumors ablated for sample size calculations in the pivotal trial (time frame: one month end point). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01478438, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.