Feasibility Study for Thyroid IndicationNCT03032198
"Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
A study testing Imagio OA/US in people with Feasibility Study for Thyroid Indication, run by Seno Medical Instruments Inc. at 2 sites in United States.
Trial summary
Thyroid Feasibility Study Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Feasibility Study for Thyroid Indication
- 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
- 37 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Dec 2017to 19 Apr 2019
- 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
- Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
- Have an undiagnosed suspicious solid or mostly solid thyroid nodule.;
- 18 years of age or older at the time of consent;
- Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
- 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.
Who cannot join
- Are prisoners;
- 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),
- Previous or on-going radioactive iodine treatment.
- Nodule to be biopsied is greater than 3.0 cm in maximum diameter;
- Is pregnant;
- Have an acute or a chronic hematoma and/or acute ecchymosis of the thyroid;
Show all 11Show fewer
- Is experiencing photo-toxicity or photo-sensitivity or is undergoing treatment for a photo-sensitive condition such as porphyria or lupus erythematosus;
- Patient has received chemotherapy for any type of cancer within 90 days from date of screening CDU;
- Have had previous image guided FNAB or surgical biopsy of the target nodule of interest within the 45 days of baseline Imagio Scan;
- 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,
- Patient has previously participated in this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Invision Sally Jobe
Greenwood Village, Colorado, 80111
UT Health Science Center
San Antonio, Texas, 78229
About this study
Official title: "Early R&D Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
Thyroid Feasibility Study
Read the 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
- Conditions
- Feasibility Study for Thyroid Indication
- Being tested
- Imagio OA/US
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Imagio OA/USDevice
Also called opto-acoustic gray-scale ultrasound
Diagnostic opto-acoustic gray-scale ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Imagio OA/US Scan | Experimental | Imagio opto-acoustic gray-scale ultrasound scan Receives: Device: Imagio OA/US |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2017 (estimated)
- Study start4 Dec 2017
- Primary completion17 Jun 2018
- Study completion19 Apr 2019
Why it stopped: Revision to over all corporate strategy
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 Feasibility Study for Thyroid IndicationStudies 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seno Medical Instruments Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tom Stavros, MD, Principal investigator, Seno Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032198
- Sponsor's protocol ID
- Thyroid-01
- Status last verified
- Jul 2022
- First submitted
- 20 Jan 2017
- Last updated
- 2 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Early R&D Clinical Evaluation of Opto-Acoustic Tomography for Detection and Diagnostic Differentiation of Thyroid Nodules"
- ClinicalTrials.gov ID
- NCT03032198
- Acronym / sponsor ID
- Thyroid-01
- Conditions
- Feasibility Study for Thyroid Indication
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Revision to over all corporate strategy
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Seno Medical Instruments Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 17 Jun 2018 (actual)
- Study completion
- 19 Apr 2019 (actual)
- First posted
- 26 Jan 2017 (estimated)
- Results
- Posted 13 Jul 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imagio OA/US Scan | Experimental | Device: Imagio OA/USImagio opto-acoustic gray-scale ultrasound scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have been informed of the nature of the study and provided written informed consent, prior to initiation of any study activities;
- Have an undiagnosed suspicious solid or mostly solid thyroid nodule.;
- 18 years of age or older at the time of consent;
- Are willing and able to complete all procedures and assessments in accordance with the clinical protocol; and,
- 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.
Key exclusion criteria (11 listed)
- Are prisoners;
- 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),
- Previous or on-going radioactive iodine treatment.
- Nodule to be biopsied is greater than 3.0 cm in maximum diameter;
- Is pregnant;
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/USAlso: opto-acoustic gray-scale ultrasoundDiagnostic opto-acoustic gray-scale ultrasound | Device | Imagio OA/US Scan |
Primary outcome
Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules.
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Tom Stavros, MD principal investigator
Seno Medical, Inc.
2 sites 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 Feasibility Study for Thyroid Indication, run by Seno Medical Instruments Inc. at 2 sites 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 13 Jul 2022). 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?
Initial Assessment of Imagio's Ability to Distinguish Between Benign and Malignant Thyroid Nodules. (time frame: 12-24 months). 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 2 Aug 2022.