Breast CancerIGAR-Breast-TONCT03734432
IGAR-Breast TeleOp Trial
A study testing IGAR-Breast TeleOp in people with Breast Cancer, run by McMaster University at 3 sites in Canada.
Trial summary
The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IGAR-Breast TeleOp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 3 sitesCanada
- Study dates
- 1 Jan 2019to 31 Dec 2019
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female subjects aged ≥ 18 years who require MRI-guided breast biopsy for diagnosis and/or staging Subjects are able to tolerate procedures for the MRI
Who cannot join
- Subjects who refuse or are unable to give free and informed consent Subjects requiring more than one breast biopsy Subjects with breast implants or other foreign bodies Subjects for whom investigator determines IGAR-Breast enabled MRI-guided breast biopsy is not possible (size of subject, location of lesion, size of breast, etc.) Subjects who are pregnant or who plan to become pregnant during the course of the study
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
St. Josephs Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Mehran Anvari, 9055221155 ext. 35058, anvari@mcmaster.ca
Karen Barlow, 905-522-1155 ext. 33739, kbarlow@stjoes.ca
Imagix - Radiologie Saint-Laurent
Saint-Laurent, Quebec, H4R 0B7
Nathalie Duchesne, nathalie.duchesne@me.com
Nathalie Duchesne
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Belinda Curpen, Belinda.Curpen@sunnybrook.ca
Carrie Betel, carrie.betel@sunnybrook.ca
About this study
Official title: IGAR-Breast Teleoperative Clinical Investigation
The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. In addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.
Read the detailed description
In this prospective clinical trial, patients who present to the breast cancer clinic at one of the primary sites with suspected breast cancer requiring MRI-guided biopsy for diagnosis or staging will be screened consecutively. Patients who meet the inclusion criteria will be approached for consent to participate in the study. Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site. All consenting participants will be followed up for the assessment of the secondary outcome measure.
A total of 5-10 participants will be consented for the pilot investigation.
Each individual subject's participation is estimated to last approximately one week post procedure, with the trial itself expected to be completed within one year of its start date.
- Conditions
- Breast Cancer
- Being tested
- IGAR-Breast TeleOp
- Keywords
- Diagnostic, Imaging, MRI
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGAR-Breast TeleOpDevice
Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | IGAR-Breast TeleOp Receives: Device: IGAR-Breast TeleOp |
What is being measured
The primary outcome is the main question the study is designed to answer.
ability for IGAR-Breast to perform breast biopsies teleoperatively
analyzing the frequency of successful biopsy, in which the samples collected are of diagnostic quality as determined by radiologist
Measured: at time of sampling and pathological evaluation
Secondary outcomes (1)
number and frequency of adverse events, device events and procedural deviations in addition to a comparison to results from previous trials for efficacy
The number of times the local radiologist is required to participate will also be observed from a safety perspective
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start1 Jan 2019 (estimated)
- Primary completion31 Mar 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Sunnybrook Health Sciences Centre
- Responsible party
- Sponsor
- Investigators
- Mehran Anvari, Principal investigator, Csii/St Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734432
- Sponsor's protocol ID
- IGAR-TO-007
- Acronym
- IGAR-Breast-TO
- Status last verified
- Nov 2018
- First submitted
- 6 Nov 2018
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGAR-Breast Teleoperative Clinical Investigation
- ClinicalTrials.gov ID
- NCT03734432
- Acronym / sponsor ID
- IGAR-Breast-TO / IGAR-TO-007
- Conditions
- Breast Cancer
- Keywords
- Diagnostic, Imaging, MRI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Sunnybrook Health Sciences Centre
- Study start
- 1 Jan 2019 (estimated)
- Primary completion
- 31 Mar 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 8 Nov 2018 (actual)
- 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.
The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. In addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.
Detailed description
In this prospective clinical trial, patients who present to the breast cancer clinic at one of the primary sites with suspected breast cancer requiring MRI-guided biopsy for diagnosis or staging will be screened consecutively. Patients who meet the inclusion criteria will be approached for consent to participate in the study. Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site. All consenting participants will be followed up for the assessment of the secondary outcome measure.
A total of 5-10 participants will be consented for the pilot investigation.
Each individual subject's participation is estimated to last approximately one week post procedure, with the trial itself expected to be completed within one year of its start date.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: IGAR-Breast TeleOpIGAR-Breast TeleOp |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female subjects aged ≥ 18 years who require MRI-guided breast biopsy for diagnosis and/or staging Subjects are able to tolerate procedures for the MRI
Key exclusion criteria (1 listed)
- Subjects who refuse or are unable to give free and informed consent Subjects requiring more than one breast biopsy Subjects with breast implants or other foreign bodies Subjects for whom investigator determines IGAR-Breast enabled MRI-guided breast biopsy is not possible (size of subject, location of lesion, size of breast, etc.) Subjects who are pregnant or who plan to become pregnant during the course of the study
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 |
|---|---|---|
| IGAR-Breast TeleOpUpon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site. | Device | Patients |
Primary outcome
ability for IGAR-Breast to perform breast biopsies teleoperatively
Time frame: at time of sampling and pathological evaluation
analyzing the frequency of successful biopsy, in which the samples collected are of diagnostic quality as determined by radiologist
1 secondary outcome
number and frequency of adverse events, device events and procedural deviations in addition to a comparison to results from previous trials for efficacy
Time frame: During procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Individual participant dataSharing planned: No
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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.
Mehran Anvari principal investigator
Csii/St Joseph's Healthcare Hamilton
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGAR-Breast TeleOp in people with Breast Cancer, run by McMaster University at 3 sites in Canada.
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 1 inclusion and 1 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 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. 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?
Contact Karen Barlow (905-522-1155 ext. 33739, kbarlow@stjoes.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ability for IGAR-Breast to perform breast biopsies teleoperatively (time frame: at time of sampling and pathological evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2018.