Thyroid DiseasePhase 1NCT06939946
Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
A Phase 1 study testing Parathyroid auto-fluorescence imaging and Indocyanine green in people with Thyroid Disease and Thyroid Surgery, run by OPTOSURGICAL, LLC at 1 site in United States.
Trial summary
It is often challenging to tell apart the parathyroid glands from the surrounding area such as lymph nodes, fat and thyroid tissue. If the surgeons are not able to tell where the parathyroid glands are, they might accidentally be removed or damaged. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Thyroid Disease, Thyroid Surgery, Parathyroid Gland
- What is being tested?
- Parathyroid auto-fluorescence imaging and Indocyanine green
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 28 Aug 2025
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of thyroid tumors, or other conditions requiring thyroid surgery where frozen section biopsy of PTGs is deemed necessary under the surgeon's estimation.
- Plan for surgical resection of pathological PTGs.
- Subject age 18 - 70 yo.
- Subject agreement to participate
Who cannot join
- Not eligible for endocrine surgeries
- Plan for biopsy only of thyroid tumor (likely difficult to obtain sufficient tissue for both pathology analysis and study assessment)
- Subject age younger than 18 yo or older than 70 yo
- Subject refusal to participate
- Subject cognitively impaired and/or unable to provide assent.
- Allergy to indocyanine green and iodine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Feasibility Study on Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
It is often challenging to tell apart the parathyroid glands from the surrounding area such as lymph nodes, fat and thyroid tissue. If the surgeons are not able to tell where the parathyroid glands are, they might accidentally be removed or damaged. This can lead to complications such as hypocalcemia (low calcium level) requiring treatment and sometimes lead to longer hospital stay. This study is designed to test a new method (a non-invasive hand-held imaging device) to assist surgeons in identifying the parathyroid glands, in order to decrease the rate of post-operative complication.
Read the detailed description
In thyroid surgeries, it is often difficult to visually distinguish parathyroid glands (PTGs) from the surrounding anatomical structures in surgeries because of their small size and appearance that is similar to lymph nodes, fat, and thyroid tissue. Unfortunately, even with surgeons' abundant experience in thyroidectomies, unintentional injury or removal of PTGs is frequently identified due to the subjective and inconclusive localization of PTGs. Such accidental removal or injury of PTGs may lead to serious complications such as postoperative hypocalcemia or hypoparathyroidism. Therefore, there is a clear need to provide surgeons with intraoperative surgical guidance to safely identify PTGs in order to prevent the risk of surgical complications.
To meet this need, we aim to assess the ability of a new non-invasive, probe-based Hand-Held Imager (HHI) [hANDY-i, Optosurgical, LLC] to identify PTGs intraoperatively in order to help surgeons safely preserve PTGs in surgeries. Using Near-Infrared Autofluorescence Imaging (NIRAF), HHI's camera system will detect spontaneous autofluorescence signals without injection of any contrast. The probe component of the HHI will allow surgeons to conveniently and noninvasively navigate deeper areas where PTGs are difficult to reach. Should the HHI be able to discriminate PTGs from surrounding anatomical structures in the neck, the investigators hypothesize that surgeons will be better equipped to distinguish surgical margins of pathological tissue for safe resection in challenging thyroid surgeries.
Furthermore, in order to confirm the perfusion status of the PTGs indocyanine green (ICG) angiography imaging will be utilized in select cases where the blood supply deemed to be compromised, this will enable the surgeon to decide if the gland is still viable.
- Conditions
- Thyroid Disease, Thyroid Surgery, Parathyroid Gland
- Being tested
- Parathyroid auto-fluorescence imaging, Indocyanine green
- Keywords
- Thyroid surgery, Parathyroid fluorescence, Indocyanine Green
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parathyroid auto-fluorescence imagingDevice
Also called hANDY-i, Hand-Held Imager
All enrolled patients for thyroid surgery, once the thyroid gland is removed the device will be used to identify the parathyroid glands.
Indocyanine greenDrug
Also called ICG
For a select group of patients when deemed necessary by the surgeon, and when one or more parathyroid gland appear to be de vascularized ICG will be administered, A dosage of 5 mg will be injected into a peripheral IV line, followed by fluorescence imaging to determine the perfusion status of the gland.
| Study group | Role | What they receive |
|---|---|---|
| Parathyroid auto-florescence imaging | Experimental | Patients undergoing open thyroid surgery Receives: Device: Parathyroid auto-fluorescence imaging; Drug: Indocyanine green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Parathyroid Glands identified by the imager.
Once the thyroid gland is removed the imager will be used to confirm the presence of 4 parathyroid glands, and will be compared to the number of parathyroid glands seen by naked eye.
Measured: 10 minutes prior to injection of ICG
Secondary outcomes (2)
Perfusion assessment using ICG angiography.
ICG angiography will be done for some of the patients, who have signs of perfusion insufficiency, 2 mg of ICG will be administered and glands will be observed by the imager to confirm if the blood flow is intact.
Assessment will be measured as:
0 - No signs of perfusion
- - Minimal perfusion
- - Well perfused
Measured: 10 minutes after ICG injection.
Measurement of Parathyroid hormone and calcium levels.
For all patients the levels of parathyroid hormone and calcium will measured pre and post operatively.
Measured: 1 day after the surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start1 Sep 2023
- Primary completion28 Aug 2025
- Study completion28 Aug 2025
Why it stopped: The NIH-funded project period has come to an end.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid DiseaseStudies 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 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- OPTOSURGICAL, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Kaitlyn Frazier, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939946
- Sponsor's protocol ID
- IRB00224302
- Status last verified
- Sep 2026
- First submitted
- 11 Apr 2025
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Data review for each subject will be completed shortly after enrollment. The research data will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by research staff will be secured and password protected. At the end of the study, all study databases will be archived at Johns Hopkins Hospital.
Publications
Ali KM, Wolfe SA, Nagururu NV, Seo S, Han SM, Kim Y, Oh E, Kim DY, Ning B, Lee SY, Cha RJ, Tufano RP, Russell JO. Parathyroid gland detection using an intraoperative autofluorescence handheld imager - early feasibility study. Front Endocrinol (Lausanne). 2023 Jul 24;14:1190282. doi: 10.3389/fendo.2023.1190282. eCollection 2023.
PubMed 37554762Kim Y, Lee HC, Kim J, Oh E, Yoo J, Ning B, Lee SY, Ali KM, Tufano RP, Russell JO, Cha J. A coaxial excitation, dual-red-green-blue/near-infrared paired imaging system toward computer-aided detection of parathyroid glands in situ and ex vivo. J Biophotonics. 2022 Aug;15(8):e202200008. doi: 10.1002/jbio.202200008. Epub 2022 Apr 20.
PubMed 35340114
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Feasibility Study on Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
- ClinicalTrials.gov ID
- NCT06939946
- Acronym / sponsor ID
- IRB00224302
- Conditions
- Thyroid Disease, Thyroid Surgery, Parathyroid Gland
- Keywords
- Thyroid surgery, Parathyroid fluorescence, Indocyanine Green
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The NIH-funded project period has come to an end.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- OPTOSURGICAL, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Johns Hopkins University
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 28 Aug 2025 (actual)
- Study completion
- 28 Aug 2025 (actual)
- First posted
- 23 Apr 2025 (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.
It is often challenging to tell apart the parathyroid glands from the surrounding area such as lymph nodes, fat and thyroid tissue. If the surgeons are not able to tell where the parathyroid glands are, they might accidentally be removed or damaged. This can lead to complications such as hypocalcemia (low calcium level) requiring treatment and sometimes lead to longer hospital stay. This study is designed to test a new method (a non-invasive hand-held imaging device) to assist surgeons in identifying the parathyroid glands, in order to decrease the rate of post-operative complication.
Detailed description
In thyroid surgeries, it is often difficult to visually distinguish parathyroid glands (PTGs) from the surrounding anatomical structures in surgeries because of their small size and appearance that is similar to lymph nodes, fat, and thyroid tissue. Unfortunately, even with surgeons' abundant experience in thyroidectomies, unintentional injury or removal of PTGs is frequently identified due to the subjective and inconclusive localization of PTGs. Such accidental removal or injury of PTGs may lead to serious complications such as postoperative hypocalcemia or hypoparathyroidism. Therefore, there is a clear need to provide surgeons with intraoperative surgical guidance to safely identify PTGs in order to prevent the risk of surgical complications.
To meet this need, we aim to assess the ability of a new non-invasive, probe-based Hand-Held Imager (HHI) [hANDY-i, Optosurgical, LLC] to identify PTGs intraoperatively in order to help surgeons safely preserve PTGs in surgeries. Using Near-Infrared Autofluorescence Imaging (NIRAF), HHI's camera system will detect spontaneous autofluorescence signals without injection of any contrast. The probe component of the HHI will allow surgeons to conveniently and noninvasively navigate deeper areas where PTGs are difficult to reach. Should the HHI be able to discriminate PTGs from surrounding anatomical structures in the neck, the investigators hypothesize that surgeons will be better equipped to distinguish surgical margins of pathological tissue for safe resection in challenging thyroid surgeries.
Furthermore, in order to confirm the perfusion status of the PTGs indocyanine green (ICG) angiography imaging will be utilized in select cases where the blood supply deemed to be compromised, this will enable the surgeon to decide if the gland is still viable.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parathyroid auto-florescence imaging | Experimental | Device: Parathyroid auto-fluorescence imaging, Drug: Indocyanine greenPatients undergoing open thyroid surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of thyroid tumors, or other conditions requiring thyroid surgery where frozen section biopsy of PTGs is deemed necessary under the surgeon's estimation.
- Plan for surgical resection of pathological PTGs.
- Subject age 18 - 70 yo.
- Subject agreement to participate
Key exclusion criteria (6 listed)
- Not eligible for endocrine surgeries
- Plan for biopsy only of thyroid tumor (likely difficult to obtain sufficient tissue for both pathology analysis and study assessment)
- Subject age younger than 18 yo or older than 70 yo
- Subject refusal to participate
- Subject cognitively impaired and/or unable to provide assent.
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 |
|---|---|---|
| Parathyroid auto-fluorescence imagingAlso: hANDY-i, Hand-Held ImagerAll enrolled patients for thyroid surgery, once the thyroid gland is removed the device will be used to identify the parathyroid glands. | Device | Parathyroid auto-florescence imaging |
| Indocyanine greenAlso: ICGFor a select group of patients when deemed necessary by the surgeon, and when one or more parathyroid gland appear to be de vascularized ICG will be administered, A dosage of 5 mg will be injected into a peripheral IV line, followed by fluorescence imaging to determine the perfusion status of the gland. | Drug | Parathyroid auto-florescence imaging |
Primary outcome
Number of Parathyroid Glands identified by the imager.
Time frame: 10 minutes prior to injection of ICG
Once the thyroid gland is removed the imager will be used to confirm the presence of 4 parathyroid glands, and will be compared to the number of parathyroid glands seen by naked eye.
2 secondary outcomes
Perfusion assessment using ICG angiography.
Time frame: 10 minutes after ICG injection.
Measurement of Parathyroid hormone and calcium levels.
Time frame: 1 day after the surgery.
Results and safety
The study was stopped early (reason given: The NIH-funded project period has come to an end.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Results publication: PubMed 37554762Ali KM, Wolfe SA, Nagururu NV, Seo S, Han SM, Kim Y, Oh E, Kim DY, Ning B, Lee SY, Cha RJ, Tufano RP, Russell JO. Parathyroid gland detection using an intraoperative autofluorescence handheld imager - early feasibility study. Front Endocrinol (Lausanne). 2023 Jul 24;14:1190282. doi: 10.3389/fendo.2023.1190282. eCollection 2023.
- Results publication: PubMed 35340114Kim Y, Lee HC, Kim J, Oh E, Yoo J, Ning B, Lee SY, Ali KM, Tufano RP, Russell JO, Cha J. A coaxial excitation, dual-red-green-blue/near-infrared paired imaging system toward computer-aided detection of parathyroid glands in situ and ex vivo. J Biophotonics. 2022 Aug;15(8):e202200008. doi: 10.1002/jbio.202200008. Epub 2022 Apr 20.
- Individual participant dataSharing planned: No. Data review for each subject will be completed shortly after enrollment. The research data will not include the participant's contact or identifying information. Rather, individual participants and their research data will be identified by a unique study identification number. The study data entry and study management systems used by research staff will be secured and password protected. At the end of the study, all study databases will be archived at Johns Hopkins Hospital.
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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.
Kaitlyn Frazier, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Parathyroid auto-fluorescence imaging and Indocyanine green in people with Thyroid Disease and Thyroid Surgery, run by OPTOSURGICAL, LLC 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 4 inclusion and 6 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 22 Sep 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The NIH-funded project period has come to an end.). Results are not available in the source record.
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?
Number of Parathyroid Glands identified by the imager. (time frame: 10 minutes prior to injection of ICG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06939946, which also lists 2 linked publications.
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 22 Sep 2026.