N/A
Completed N=38
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen 2 Imagio System
Breast Cancer Stage
Source: ClinicalTrials.gov NCT05022602 ↗
Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcomePrimary: Number of Participants With Imagio Image Sets Collected — 38 Participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Imagio Image Sets Collected |
38 | — |
| PRIMARY Number of Subjects With Completed Pathology Results |
23 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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.
- Has had prior benign excisional breast biopsy on breast of interest within the past 18 months.
- Currently has mastitis.
- Prisoners
Data sourced from ClinicalTrials.gov (NCT05022602). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.