Study Stopped
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Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
Early Feasibility Study on Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
1 other identifier
interventional
20
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Sep 2023
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2023
CompletedFirst Submitted
Initial submission to the registry
April 11, 2025
CompletedFirst Posted
Study publicly available on registry
April 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 28, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
August 28, 2025
CompletedDecember 19, 2025
December 1, 2025
2 years
April 11, 2025
December 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
10 minutes prior to injection of ICG
Secondary Outcomes (2)
Perfusion assessment using ICG angiography.
10 minutes after ICG injection.
Measurement of Parathyroid hormone and calcium levels.
1 day after the surgery.
Study Arms (1)
Parathyroid auto-florescence imaging
EXPERIMENTALPatients undergoing open thyroid surgery
Interventions
All enrolled patients for thyroid surgery, once the thyroid gland is removed the device will be used to identify the parathyroid glands.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OPTOSURGICAL, LLClead
- Johns Hopkins Universitycollaborator
Study Sites (1)
Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
Related Publications (2)
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.
PMID: 37554762RESULTKim 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.
PMID: 35340114RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kaitlyn Frazier, MD
Johns Hopkins University
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 11, 2025
First Posted
April 23, 2025
Study Start
September 1, 2023
Primary Completion
August 28, 2025
Study Completion
August 28, 2025
Last Updated
December 19, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share
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.