Breast CancerNCT03845907
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications
A study testing Gen 1B and Gen 1 in people with Breast Cancer, run by Seno Medical Instruments Inc. at 1 site in United States.
Trial summary
Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Gen 1B and Gen 1
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2018to 30 Dec 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has a signed and dated informed consent, prior to initiation of any study-related activities.
- Is at least 18 years of age.
- Is willing to undergo an Imagio imaging evaluation and standard Ultrasound Evaluation of the breast and axillary lymph nodes.
- Is willing and able to comply with protocol-required scans.
Who cannot join
- Is pregnant or lactating.
- Has a condition or impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, breast implants within the previous 12 months, etc.) where the duplex probe will come in contact with the subject, which could interfere with the intended field of view.
- Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline.
- Is currently undergoing phototherapy.
- Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
- Has had an adverse reaction in the past to medical laser procedures, such as laser hair removal or laser tattoo removal.
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- Has had a history of contact dermatitis induced by gold or chrome metal contact with skin.
- Has an acute or chronic hematoma and/or acute ecchymosis of the breast.
- Has had prior benign excisional breast biopsy within the past 18 months.
- Has nipple rings that cannot be removed or are not removed during Imagio evaluation.
- Currently has mastitis.
- Has focal pain in the breast.
Trial locations and contacts
1 site in 1 country.
About this study
Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects
Read the detailed description
This study performs the first clinical evaluation of the Gen1B (OA-16-1S) duplex OA/US probe. This probe includes design changes to improve reliability and performance compared to the Gen1 (OA-16-1) duplex OA/US probe. The performance of the Gen1 duplex probe is functionally equivalent to the PIONEER duplex probe (OA-15-3), which was used in previous clinical studies for suspicious breast masses.
- Conditions
- Breast Cancer
- Being tested
- Gen 1B, Gen 1
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gen 1BDevice
Diagnostic Ultrasound and Optoacoustic Imaging
Gen 1Device
Diagnostic Ultrasound and Optoacoustic Imaging
| Study group | Role | What they receive |
|---|---|---|
| Imagio Gen 1B | Active comparator | Gen 1B duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System and the Gen1B duplex probe Receives: Device: Gen 1B; Device: Gen 1 |
| Imagio Gen 1 | Active comparator | Gen 1 duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System Receives: Device: Gen 1B; Device: Gen 1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Treatment-related Events
Safety of the Gen 1B duplex Optoacoustic (OA)/ Ultrasound (US) probe in breast applications as compared to Gen 1 with respect to treatment-related events
Measured: At end of study, average of six months
Diagnostic Image Quality of Gen 1B
Independent reader comparison using questionnaire and measurements on artifacts and features of Gen 1 Gen1B probe images for pair wise comparison
Measured: At end of study, average of six months
Secondary outcomes (2)
Probe performance data comparison across skin types
The effect of skin pigmentation using the Fitzpatrick Scale (skin typing test), from Type I (always burns, never tans (palest; freckles) to Type VI never burns (deeply pigmented dark brown to darkest brown) will be used to determine similarities and differences between probes.
Measured: At end of study, average of six months
Image Quality between probes at reduced laser level
OA images with reduced laser level energy will be collected to determine via a 7 point image quality scale, where 1 is poor and 7 is best, which probe produces better images by independent readers
Measured: At end of study, average of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2019
- Study start19 Dec 2018
- Primary completion30 Dec 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Why it stopped: Data on initial patients sufficient
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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Unblinded feasibility study in healthy subjects
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seno Medical Instruments Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- A. Thomas Stavros, MD, Study director, Seno Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03845907
- Sponsor's protocol ID
- GEN1B-01
- Status last verified
- Apr 2020
- First submitted
- 7 Nov 2018
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications
- ClinicalTrials.gov ID
- NCT03845907
- Acronym / sponsor ID
- GEN1B-01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Data on initial patients sufficient
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Seno Medical Instruments Inc.Industry (pharma, biotech, devices)
- Study start
- 19 Dec 2018 (actual)
- Primary completion
- 30 Dec 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 19 Feb 2019 (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.
Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects
Detailed description
This study performs the first clinical evaluation of the Gen1B (OA-16-1S) duplex OA/US probe. This probe includes design changes to improve reliability and performance compared to the Gen1 (OA-16-1) duplex OA/US probe. The performance of the Gen1 duplex probe is functionally equivalent to the PIONEER duplex probe (OA-15-3), which was used in previous clinical studies for suspicious breast masses.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Unblinded feasibility study in healthy subjects
| Arm | Type | Receives |
|---|---|---|
| Imagio Gen 1B | Active comparator | Device: Gen 1B, Device: Gen 1Gen 1B duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System and the Gen1B duplex probe |
| Imagio Gen 1 | Active comparator | Device: Gen 1B, Device: Gen 1Gen 1 duplex probe ultrasound / optoacoustic imaging of the breast and axillary lymph node, with the IMAGIO System |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Has a signed and dated informed consent, prior to initiation of any study-related activities.
- Is at least 18 years of age.
- Is willing to undergo an Imagio imaging evaluation and standard Ultrasound Evaluation of the breast and axillary lymph nodes.
- Is willing and able to comply with protocol-required scans.
Key exclusion criteria (12 listed)
- Is pregnant or lactating.
- Has a condition or impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, breast implants within the previous 12 months, etc.) where the duplex probe will come in contact with the subject, which could interfere with the intended field of view.
- Is experiencing photo-toxicity associated with currently taking, or having taken, photosensitizing agents within the previous 72 hours such as sulfa, ampicillin, tetracycline.
- Is currently undergoing phototherapy.
- Has a history of any photosensitive disease (e.g., porphyria, lupus erythematosus) or undergoing treatment for a photosensitive disease and is experiencing photosensitivity.
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 |
|---|---|---|
| Gen 1BDiagnostic Ultrasound and Optoacoustic Imaging | Device | Imagio Gen 1, Imagio Gen 1B |
| Gen 1Diagnostic Ultrasound and Optoacoustic Imaging | Device | Imagio Gen 1, Imagio Gen 1B |
Primary outcome
Number of Subjects with Treatment-related Events
Time frame: At end of study, average of six months
Safety of the Gen 1B duplex Optoacoustic (OA)/ Ultrasound (US) probe in breast applications as compared to Gen 1 with respect to treatment-related events
Diagnostic Image Quality of Gen 1B
Time frame: At end of study, average of six months
Independent reader comparison using questionnaire and measurements on artifacts and features of Gen 1 Gen1B probe images for pair wise comparison
2 secondary outcomes
Probe performance data comparison across skin types
Time frame: At end of study, average of six months
Image Quality between probes at reduced laser level
Time frame: At end of study, average of six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- 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.
A. Thomas Stavros, MD study director
Seno Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gen 1B and Gen 1 in people with Breast Cancer, run by Seno Medical Instruments Inc. at 1 site in United States.
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 4 inclusion and 12 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: paused, as of the sponsor's last update on 6 Apr 2020. 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 United States. 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?
Number of Subjects with Treatment-related Events (time frame: At end of study, average of six months). The study lists 2 primary outcomes in all. 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 6 Apr 2020.