Breast CancerNCT05337280
OA for Breast Cancer NAC Response
A study testing Imagio OA/US in people with Breast Cancer, run by Seno Medical Instruments Inc. at 1 site in United States.
Trial summary
This is an early research and development study. The objective of this study is to determine the feasibility of the Imagio OA/US Breast Imaging System to detect complete breast cancer pathologic response to neoadjuvant therapy as assessed by functional optoacoustic features, vascular features and relative degrees of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Imagio OA/US
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2021to 4 Jan 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years and older male or female patients;
- Ipsilateral intact biopsy-proven invasive breast cancer clinical T1-T4 (by standard of care imaging), including primary or recurrent disease.
- Patient eligible to receive neoadjuvant chemotherapy
Who cannot join
- Known Stage IV disease (breast or other cancer);
- Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule);
- Patient has received chemotherapy for any type of cancer within 90 days from date of baseline Imagio OA/US exam;
- 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);
Show all 9Show fewer
- Is undergoing treatment for a photosensitive disease and is experiencing photosensitivity;
- Pregnancy;
- Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening visit that may have an impact on clinical outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Assessing Breast Cancer Neoadjuvant Therapy Response Using Imagio Opto-Acoustic Imaging
This is an early research and development study. The objective of this study is to determine the feasibility of the Imagio OA/US Breast Imaging System to detect complete breast cancer pathologic response to neoadjuvant therapy as assessed by functional optoacoustic features, vascular features and relative degrees of oxygenation/deoxygenation
Read the detailed description
The use of neoadjuvant systemic therapy in the treatment of breast cancer patients is increasing beyond the scope of locally advanced disease. Imaging provides important information in assessing response to therapy as a complement to conventional tumor measurements via physical examination. Tumor response to neoadjuvant therapy can also provide prognostic information. As stated in the background section, the attainment of pCR after completion of neoadjuvant therapy and surgical resection is associated with improved disease-free survival [1-3]. This correlation is especially strong for Triple-receptor negative (ER, PR negative and HER-2 non amplified), and HER-2 positive breast cancer. Studies of neoadjuvant therapy have used a variety of methods for assessing tumor response. Currently, there are no established clinical practice guidelines for how best to assess tumor response to neoadjuvant therapy. Typically, patients undergo conventional breast imaging (mammography and US) and physical examination, and DCE-MRI in selected cases.
The Imagio OA/US technology is an alternative imaging technology that demonstrates both gray scale ultrasound morphologic information, including size measurements, and functional information that includes presence or absence of tumor angiogenesis, degree of angiogenesis, and relative degrees of oxygenation and deoxygenation of hemoglobin.
- Conditions
- Breast Cancer
- Being tested
- Imagio OA/US
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagio OA/USDevice
Imagio optoacoustic/ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Imagio OA/US | Experimental | Imagio OA/US Imaging Receives: Device: Imagio OA/US |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of masses that may exhibit qualitative changes in accordance with Functional Feature Scale as assessed by Imagio OA/US over the course of baseline though follow-up timepoints
Feature scores per mass derived per Feature Score Scale (0-6 and 0-5 scoring- lower score mean most likely benign) per 5 mass features (External Peripheral Zone, External Capsular Boundary, Internal Shape, Internal Echotexture, Internal Sound ) used to predict number of masses that demonstrated response or no response at all time points (baseline, cycle 2, mid cycle and pre surgical) to chemotherapy treatment
Measured: Baseline to Post Surgical Assessment at 6 months
Number of masses that correlate with chemotherapy response/no response as assessed by Functional Feature Score Scale at all study timepoints to predict optimal timing for Imagio imaging
Number of masses assessed at baseline and follow-up timepoints - cycle 2, mid cycle and pre surgical f/u that correlate with feature score (External Peripheral Zone, External Capsular, Internal Vessel Score, Internal Total Hemoglobin, Internal Deoxygenated Blush) changes assessed by Feature Score Scale (0-6 nd 0-5 scores depending on feature) and pathologic complete response (pCR) to determine optimal timing for imaging.
Measured: Baseline to Post Surgical Assessment at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start30 Mar 2021
- Primary completion4 Jan 2023
- Study completion4 Jan 2023
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
- Sequential
- Model description
- This is a single center sequential design
- Masking
- None (open label)
- Enrolment
- 20 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
- Basak Dogan, MD, Principal investigator, UT Southwestern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05337280
- Sponsor's protocol ID
- NEO-01
- Status last verified
- Apr 2023
- First submitted
- 10 Feb 2022
- Last updated
- 12 Apr 2023
- 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 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Assessing Breast Cancer Neoadjuvant Therapy Response Using Imagio Opto-Acoustic Imaging
- ClinicalTrials.gov ID
- NCT05337280
- Acronym / sponsor ID
- NEO-01
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seno Medical Instruments Inc.Industry (pharma, biotech, devices)
- Collaborators
- American College of Radiology
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 4 Jan 2023 (actual)
- First posted
- 20 Apr 2022 (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.
This is an early research and development study. The objective of this study is to determine the feasibility of the Imagio OA/US Breast Imaging System to detect complete breast cancer pathologic response to neoadjuvant therapy as assessed by functional optoacoustic features, vascular features and relative degrees of oxygenation/deoxygenation
Detailed description
The use of neoadjuvant systemic therapy in the treatment of breast cancer patients is increasing beyond the scope of locally advanced disease. Imaging provides important information in assessing response to therapy as a complement to conventional tumor measurements via physical examination. Tumor response to neoadjuvant therapy can also provide prognostic information. As stated in the background section, the attainment of pCR after completion of neoadjuvant therapy and surgical resection is associated with improved disease-free survival [1-3]. This correlation is especially strong for Triple-receptor negative (ER, PR negative and HER-2 non amplified), and HER-2 positive breast cancer. Studies of neoadjuvant therapy have used a variety of methods for assessing tumor response. Currently, there are no established clinical practice guidelines for how best to assess tumor response to neoadjuvant therapy. Typically, patients undergo conventional breast imaging (mammography and US) and physical examination, and DCE-MRI in selected cases.
The Imagio OA/US technology is an alternative imaging technology that demonstrates both gray scale ultrasound morphologic information, including size measurements, and functional information that includes presence or absence of tumor angiogenesis, degree of angiogenesis, and relative degrees of oxygenation and deoxygenation of hemoglobin.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single center sequential design
| Arm | Type | Receives |
|---|---|---|
| Imagio OA/US | Experimental | Device: Imagio OA/USImagio OA/US Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older male or female patients;
- Ipsilateral intact biopsy-proven invasive breast cancer clinical T1-T4 (by standard of care imaging), including primary or recurrent disease.
- Patient eligible to receive neoadjuvant chemotherapy
Key exclusion criteria (9 listed)
- Known Stage IV disease (breast or other cancer);
- Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or 4 cm of the nodule);
- Patient has received chemotherapy for any type of cancer within 90 days from date of baseline Imagio OA/US exam;
- 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;
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 |
|---|---|---|
| Imagio OA/USImagio optoacoustic/ultrasound | Device | Imagio OA/US |
Primary outcome
The number of masses that may exhibit qualitative changes in accordance with Functional Feature Scale as assessed by Imagio OA/US over the course of baseline though follow-up timepoints
Time frame: Baseline to Post Surgical Assessment at 6 months
Feature scores per mass derived per Feature Score Scale (0-6 and 0-5 scoring- lower score mean most likely benign) per 5 mass features (External Peripheral Zone, External Capsular Boundary, Internal Shape, Internal Echotexture, Internal Sound ) used to predict number of masses that demonstrated response or no response at all time points (baseline, cycle 2, mid cycle and pre surgical) to chemotherapy treatment
Number of masses that correlate with chemotherapy response/no response as assessed by Functional Feature Score Scale at all study timepoints to predict optimal timing for Imagio imaging
Time frame: Baseline to Post Surgical Assessment at 6 months
Number of masses assessed at baseline and follow-up timepoints - cycle 2, mid cycle and pre surgical f/u that correlate with feature score (External Peripheral Zone, External Capsular, Internal Vessel Score, Internal Total Hemoglobin, Internal Deoxygenated Blush) changes assessed by Feature Score Scale (0-6 nd 0-5 scores depending on feature) and pathologic complete response (pCR) to determine optimal timing for imaging.
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 12 Apr 2023.
- 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.
Basak Dogan, MD principal investigator
UT Southwestern
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 OA/US 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 3 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 12 Apr 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?
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?
The number of masses that may exhibit qualitative changes in accordance with Functional Feature Scale as assessed by Imagio OA/US over the course of baseline though follow-up timepoints (time frame: Baseline to Post Surgical Assessment at 6 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 12 Apr 2023.