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

NCT06939946 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-19

No results posted yet for this study

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.

Conditions

  • Thyroid Disease
  • Thyroid Surgery
  • Parathyroid Gland

Interventions

DEVICE

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.

DRUG

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.

Sponsors & Collaborators

Principal Investigators

  • Kaitlyn Frazier, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-01
Primary Completion
2025-08-28
Completion
2025-08-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06939946 on ClinicalTrials.gov