Clinical trial NCT06939946: Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
Official title: Early Feasibility Study on Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Thyroid Disease
Thyroid Surgery
Parathyroid Gland
Keywords: Thyroid surgery
Parathyroid fluorescence
Indocyanine Green
Lead sponsor: OPTOSURGICAL, LLC
Sponsor class: INDUSTRY
Collaborators: name: Johns Hopkins University
First posted: 2025-04-23
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Number of Parathyroid Glands identified by the imager.
timeFrame: 10 minutes prior to injection of ICG
Secondary outcomes:
measure: Perfusion assessment using ICG angiography.
timeFrame: 10 minutes after ICG injection.
measure: Measurement of Parathyroid hormone and calcium levels.
timeFrame: 1 day after the surgery.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kaitlyn Frazier, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.