Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications

Breast Cancer Clinical Trial

Official title:

Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03845907
• Other study ID #: GEN1B-01
• Status: Suspended
• Phase: N/A
• Start date: December 19, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: April 2020
• Source: Seno Medical Instruments Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 4
• Est. completion date: December 30, 2020
• Est. primary completion date: December 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

• 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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Gen 1B
Diagnostic Ultrasound and Optoacoustic Imaging
• Gen 1
Diagnostic Ultrasound and Optoacoustic Imaging

Locations

Country	Name	City	State
United States	Seno Medical	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Seno Medical Instruments Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At end of study, average of six months
Primary	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	At end of study, average of six months
Secondary	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.	At end of study, average of six months
Secondary	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	At end of study, average of six months