Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)

NCT ID: NCT06939946

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2025-08-28

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.

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

Keywords

Thyroid surgery; Parathyroid fluorescence; Indocyanine Green

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Parathyroid auto-florescence imaging

Patients undergoing open thyroid surgery

Group Type: EXPERIMENTAL

Parathyroid auto-fluorescence imaging

Intervention Type: DEVICE

All enrolled patients for thyroid surgery, once the thyroid gland is removed the device will be used to identify the parathyroid glands.

Indocyanine green

Intervention Type: DRUG

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.

Interventions

Parathyroid auto-fluorescence imaging

All enrolled patients for thyroid surgery, once the thyroid gland is removed the device will be used to identify the parathyroid glands.

Intervention Type: DEVICE

Indocyanine green

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.

Intervention Type: DRUG

Other Intervention Names

hANDY-i; Hand-Held Imager; ICG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: collaborator

OPTOSURGICAL, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kaitlyn Frazier, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Hospital

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 37554762 (View on PubMed)

Kim 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.

Reference Type: RESULT

PMID: 35340114 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IRB00224302

Identifier Type: -

Identifier Source: org_study_id