Breast Cancer Invasive NosPhase 1NCT02794064
A Prototype Tri-modal Imaging Device for Breast Cancer
A Phase 1 study testing Tri-modal imaging in people with Breast Cancer Invasive Nos and Primary Invasive Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Breast conservation surgery (BCS) is performed on patients with breast cancer with the intent to resect and completely remove the tumour while conserving as much of the surrounding normal tissue as possible. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Invasive Nos, Primary Invasive Breast Cancer
- What is being tested?
- Tri-modal imaging
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- May 2016to Feb 2017
- Phase
- Phase 1
- 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 patients with biopsy-confirmed first primary invasive unilateral breast cancer
- 18 years of age or older
- Have consented to standard of care surgery (lumpectomy, mastectomy) for primary invasive breast cancer, with or without auxiliary lymph node dissection
- Have had pre-surgical imaging of the affected breast and (where applicable) lymph notes (Note: additional imaging may also be done day of scheduled surgery i.e. mammography, nuclear medicine)
- Have existing biopsies banked at the hospital
- Surgery scheduled at Princess Margaret Hospital
- Tumor size of 1 cm or larger
Who cannot join
- Inability to provide informed consent
- Pre-operative therapy for current breast cancer (including chemotherapy, endocrine therapy and radiotherapy)
- history of other previous cancer requiring therapy (including chemotherapy, endocrine therapy and radiotherapy) within the past 12 months
- History of photosensitivity, skin disease or recurrent disease
- Pregnancy
- Absence of in-house biopsy in tissue bank
- Bilateral breast cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Evaluation of a Prototype Tri-modal Imaging Instrument for Guiding Breast Cancer Surgery
Breast conservation surgery (BCS) is performed on patients with breast cancer with the intent to resect and completely remove the tumour while conserving as much of the surrounding normal tissue as possible. Currently, there is no way for surgeons to determine the adequacy of surgical resection in real-time during surgery; the assessment of surgical margins requires histological examination that is not available in real-time and is impractical in most clinical cases. This results in a re-excision rate of 23% among Canadian women in order to achieve optimal surgical margins. In addition, the presence or absence of cancer in tumor draining lymph nodes is recognized as a key element for breast cancer staging; however, lymph node dissection can be associated with overtreatment and morbidity (nerve damage and post surgical lymphedema) and histological analysis of nodes can be time consuming and thus delay subsequent procedures. In an effort to address these issues, we have designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system that performs three complementary imaging modalities (tri-modal): ultrasound (US), photoacoustic (PA) and fluorescence (FL).
This first-in-human pilot study will recruit 10 breast cancer patients undergoing breast conserving surgery at Princess Margaret Hospital (Toronto, Canada). The study is designed to test our tri-modal (US, PA, FL) imaging technology in breast cancer patients. The overall goal is to obtain initial information on the technical feasibility of the tri-modal system in a peri-operative setting and to confirm the anticipated safety of the procedures. Additionally, it will provide initial data on the ability of this system to detect/localize primary breast cancer lesions and cancer-involved lymph nodes prior to surgery.
- Being tested
- Tri-modal imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tri-modal imagingDevice
This tri-modal imaging system was developed in collaboration with Sogang University and is composed of three subsystems: ultrasound, photoacoustic and fluorescence. For this study, the fluorescence subsystem will not be used. The photoacoustic and ultrasound subsystems and data acquisition are controlled by a single workstation. The complete system is Canadian Standards Association (CSA) certified
| Study group | Role | What they receive |
|---|---|---|
| Tri-modal imaging | Experimental | Ultrasound and photoacoustic imaging of breast and adjacent lymph nodes. Imaging time: Approximately 30 minutes Receives: Device: Tri-modal imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detect/localize breast tumours and lymph nodes in vivo by using tri-modal imaging
Measured: Baseline (tri-modal imaging), post-surgical (pathology report); an average of 1-2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Invasive NosStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02794064
- Sponsor's protocol ID
- 14-8692
- Status last verified
- Feb 2018
- First submitted
- 27 May 2016
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a Prototype Tri-modal Imaging Instrument for Guiding Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT02794064
- Acronym / sponsor ID
- 14-8692
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Jun 2016 (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.
Breast conservation surgery (BCS) is performed on patients with breast cancer with the intent to resect and completely remove the tumour while conserving as much of the surrounding normal tissue as possible. Currently, there is no way for surgeons to determine the adequacy of surgical resection in real-time during surgery; the assessment of surgical margins requires histological examination that is not available in real-time and is impractical in most clinical cases. This results in a re-excision rate of 23% among Canadian women in order to achieve optimal surgical margins. In addition, the presence or absence of cancer in tumor draining lymph nodes is recognized as a key element for breast cancer staging; however, lymph node dissection can be associated with overtreatment and morbidity (nerve damage and post surgical lymphedema) and histological analysis of nodes can be time consuming and thus delay subsequent procedures. In an effort to address these issues, we have designed and constructed, in collaboration with Sogang University, Seoul, S. Korea, a novel imaging system that performs three complementary imaging modalities (tri-modal): ultrasound (US), photoacoustic (PA) and fluorescence (FL).
This first-in-human pilot study will recruit 10 breast cancer patients undergoing breast conserving surgery at Princess Margaret Hospital (Toronto, Canada). The study is designed to test our tri-modal (US, PA, FL) imaging technology in breast cancer patients. The overall goal is to obtain initial information on the technical feasibility of the tri-modal system in a peri-operative setting and to confirm the anticipated safety of the procedures. Additionally, it will provide initial data on the ability of this system to detect/localize primary breast cancer lesions and cancer-involved lymph nodes prior to surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tri-modal imaging | Experimental | Device: Tri-modal imagingUltrasound and photoacoustic imaging of breast and adjacent lymph nodes. Imaging time: Approximately 30 minutes |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients with biopsy-confirmed first primary invasive unilateral breast cancer
- 18 years of age or older
- Have consented to standard of care surgery (lumpectomy, mastectomy) for primary invasive breast cancer, with or without auxiliary lymph node dissection
- Have had pre-surgical imaging of the affected breast and (where applicable) lymph notes (Note: additional imaging may also be done day of scheduled surgery i.e. mammography, nuclear medicine)
- Have existing biopsies banked at the hospital
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Pre-operative therapy for current breast cancer (including chemotherapy, endocrine therapy and radiotherapy)
- history of other previous cancer requiring therapy (including chemotherapy, endocrine therapy and radiotherapy) within the past 12 months
- History of photosensitivity, skin disease or recurrent disease
- Pregnancy
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 |
|---|---|---|
| Tri-modal imagingThis tri-modal imaging system was developed in collaboration with Sogang University and is composed of three subsystems: ultrasound, photoacoustic and fluorescence. For this study, the fluorescence subsystem will not be used. The photoacoustic and ultrasound subsystems and data acquisition are controlled by a single workstation. The complete system is Canadian Standards Association (CSA) certified | Device | Tri-modal imaging |
Primary outcome
Detect/localize breast tumours and lymph nodes in vivo by using tri-modal imaging
Time frame: Baseline (tri-modal imaging), post-surgical (pathology report); an average of 1-2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2018.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tri-modal imaging in people with Breast Cancer Invasive Nos and Primary Invasive Breast Cancer, run by University Health Network, Toronto at 1 site 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detect/localize breast tumours and lymph nodes in vivo by using tri-modal imaging (time frame: Baseline (tri-modal imaging), post-surgical (pathology report); an average of 1-2 weeks). 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 26 Feb 2018.