Breast Cancer StageNCT05022602
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System
A study testing Imagio in people with Breast Cancer Stage, run by Seno Medical Instruments Inc. at 1 site in United States.
Trial summary
This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer Stage
- What is being tested?
- Imagio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2021to 17 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All sexes
- No healthy volunteers
- 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.
- Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.
- Is willing and able to comply with protocol-required scans
Who cannot join
- Is pregnant or lactating.
- Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) 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 some sulfur containing drugs, 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.
Show all 9Show fewer
- Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
- Currently has mastitis.
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).
Read the detailed description
- Obtain ultrasound only probe images and duplex probe OA/US (both gray scale and OA) probe images. This includes doppler and elastography imaging with the gray scale only ultrasound probe and ultrasound mode of the duplex OA/US probe.
- Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable))
- Conditions
- Breast Cancer Stage
- Being tested
- Imagio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ImagioDevice
Imagio - both ultrasound probe and Duplex OA probe
| Study group | Role | What they receive |
|---|---|---|
| Imagio | Experimental | Imagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes Receives: Device: Imagio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Imagio Image Sets Collected
Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled.
Measured: Baseline
Number of Subjects With Completed Pathology Results
Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2021
- Study start19 Aug 2021
- Primary completion17 Feb 2022
- Study completion17 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast Cancer StageStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seno Medical Instruments Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- American College of Radiology
- Responsible party
- Sponsor
- Investigators
- Pam Otto, MD, Principal investigator, UTHSC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05022602
- Sponsor's protocol ID
- Gen 2 - 01
- Status last verified
- Mar 2023
- First submitted
- 20 Aug 2021
- Last updated
- 29 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System
- ClinicalTrials.gov ID
- NCT05022602
- Acronym / sponsor ID
- Gen 2 - 01
- Conditions
- Breast Cancer Stage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Seno Medical Instruments Inc.Industry (pharma, biotech, devices)
- Collaborators
- American College of Radiology
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 17 Feb 2022 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 26 Aug 2021 (actual)
- Results
- Posted 29 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study performs the first clinical evaluation of the Gen 2 Imagio System in a clinical setting to assess image quality with both the IUS ultrasound only probe and the OA/US (duplex probe).
Detailed description
- Obtain ultrasound only probe images and duplex probe OA/US (both gray scale and OA) probe images. This includes doppler and elastography imaging with the gray scale only ultrasound probe and ultrasound mode of the duplex OA/US probe.
- Provide breast and lymph node pathology results (except BI-RADS 1, 2 and 3 (as applicable))
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imagio | Experimental | Device: ImagioImagio Grayscale only probe and Imagio Duplex probe in ultrasound only and OA modes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not 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.
- Have been referred for a breast US because of a breast lesion/mass finding via a palpable lump or per standard of care imaging.
- Is willing and able to comply with protocol-required scans
Key exclusion criteria (9 listed)
- Is pregnant or lactating.
- Has a condition or breast impediment (i.e. insect bites, poison ivy, rash, open wounds, chafing of the skin, scar, tattoos, moles, hematoma, nipple rings, etc.) 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 some sulfur containing drugs, 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 |
|---|---|---|
| ImagioImagio - both ultrasound probe and Duplex OA probe | Device | Imagio |
Primary outcome
Number of Participants With Imagio Image Sets Collected
Time frame: Baseline
Obtain ultrasound only probe images and OA/US (both gray scale and OA) probe images as measured by the receipt of image sets for each subject enrolled.
Number of Subjects With Completed Pathology Results
Time frame: Baseline
Provide breast pathology results per subject (except BI-RADS 1, 2 and 3 (as applicable)) if subject's study mass is biopsied
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Pam Otto, MD principal investigator
UTHSC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Imagio in people with Breast Cancer Stage, 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 9 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 29 Mar 2023. 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?
Yes. Results are posted in the registry (first posted 29 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Participants With Imagio Image Sets Collected (time frame: Baseline). 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 29 Mar 2023.