Feasibility Study for Thyroid Indication
Conditions
Brief summary
Thyroid Feasibility Study
Detailed description
This is an early R&D Feasibility study to assess Imagio OA/US's ability to optimize the device algorithm specific to thyroid in order to detect the difference between benign and malignant thyroid nodules
Interventions
DEVICEImagio OA/US
Diagnostic opto-acoustic gray-scale ultrasound
Sponsors
Seno Medical Instruments Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities; 2. Have an undiagnosed suspicious solid or mostly solid thyroid nodule.; 3. 18 years of age or older at the time of consent; 4. Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and, 5. Have received recommendation for and are scheduled for an ultrasound guided FNAB, ultrasound guided core biopsy, excisional biopsy, lobectomy or complete thyroidectomy of at least one thyroid nodule.
Exclusion criteria
1. Are prisoners; 2. 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), 3. Previous or on-going radioactive iodine treatment. 4. Nodule to be biopsied is greater than 3.0 cm in maximum diameter; 5. Is pregnant; 6. Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid; 7. Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus; 8. Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU; 9. Have had previous image guided FNAB or surgical biopsy of the target nodule of interest within the 45 days of baseline Imagio Scan; 10. Patient has participated in a clinical study of an investigational drug or device within 3 months prior to screening CDU that may have an impact on clinical outcomes; and, 11. Patient has previously participated in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules. | 12-24 months | The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects. |
Countries
United States
Participant flow
Recruitment details
Trial was terminated early due to corporate strategy changes
Participants by arm
| Arm | Count |
|---|---|
| Imagio OA/US Scan Imagio opto-acoustic gray-scale ultrasound scan
Imagio OA/US: Diagnostic opto-acoustic gray-scale ultrasound | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Screen Fail | 1 |
Baseline characteristics
| Characteristic | Imagio OA/US Scan |
|---|---|
| Age, Continuous | 57 Years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 36 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 26 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 36 |
| other Total, other adverse events | 1 / 36 |
| serious Total, serious adverse events | 0 / 36 |
Outcome results
Primary
Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.
The primary objective of this feasibility study is to provide an initial assessment of Imagio OA's ability to distinguish between benign and malignant thyroid nodules, and when appropriate, between benign and metastatic cervical lymph nodes in subjects.
Time frame: 12-24 months
Population: This Early R\&D Development Study was terminated early due to change in corporate strategy. The study was discontinued before we initiated the independent reader portion of the study which would have been the basis for producing the data that is needed for analyzing this endpoint.