Hand-Held Imager for Thyroid Disease

Overseen By Eugene Oh, MSE

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: OPTOSURGICAL, LLC

Disqualifiers: Age, Cognitive impairment, Allergies, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

64 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Indocyanine green, Parathyroid auto-fluorescence imaging for thyroid disease?

Research shows that using autofluorescence imaging helps doctors see parathyroid glands more clearly during surgery, which can prevent accidental damage. This technique has been effective in identifying parathyroid glands by making them appear brighter compared to surrounding tissues, improving surgical outcomes. ^{1 2 3 4 5}

Is the hand-held imager for thyroid disease safe for humans?

There is no specific safety data available for the hand-held imager for thyroid disease, but similar imaging agents like gadolinium-based contrast agents have been generally safe in healthy people, though they can cause issues in those with severe kidney problems. ^{6 7 8 9 10}

How does the treatment Parathyroid auto-fluorescence imaging differ from other treatments for thyroid disease?

Parathyroid auto-fluorescence imaging is unique because it uses a special imaging device to visualize the parathyroid glands in real-time during surgery, helping to prevent accidental damage. This technique is different from other treatments as it does not require contrast agents and provides high-resolution images using near-infrared light, making it a low-cost and effective option for identifying parathyroid glands. ^{2 4 5 11 12}

Research Team

Kaitlyn Frazier, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

This trial is for individuals undergoing thyroid surgery who may benefit from a new imaging technique to help surgeons identify parathyroid glands and avoid damaging them, potentially reducing complications like low calcium levels.

Inclusion Criteria

Subject agreement to participate

I need thyroid surgery and a biopsy to check my parathyroid glands.

I am scheduled for surgery to remove my parathyroid glands.

Exclusion Criteria

Allergy to indocyanine green and iodine

I do not want to participate in the trial.

I cannot have surgery to remove hormone-producing glands.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Imaging

Participants undergo open thyroid surgery with intraoperative parathyroid gland identification using a hand-held imager

1 day

1 visit (in-person)

Post-operative Monitoring

Measurement of parathyroid hormone and calcium levels pre and post operatively

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery

4 weeks

Treatment Details

Interventions

• Indocyanine green
• Parathyroid auto-fluorescence imaging

Trial Overview The study tests a non-invasive hand-held imager (HHI) that helps distinguish the parathyroid glands from surrounding tissues during surgery. The goal is to lower post-operative issues by improving gland identification.

Participant Groups

Group I: Parathyroid auto-florescence imaging Experimental Treatment 2 Interventions

Patients undergoing open thyroid surgery

Who Is Running the Clinical Trial?

OPTOSURGICAL, LLC

Lead Sponsor

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Findings from Research

In a study of 115 pediatric patients who underwent fluorescein angiography (FA), no significant adverse events were directly associated with the procedure, indicating it is safe for use in children.

Younger patients, particularly those under 3.8 years old, were more likely to require inpatient FA, while older patients typically underwent the procedure as outpatients, suggesting age-related differences in the need for this imaging technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Potential Systemic Adverse Events Related to Fluorescein Angiography in Pediatric Patients. Chee, RI., Gupta, MP., Valikodath, NG., et al.[2021]

Gadoxetic acid, a gadolinium-based contrast agent, showed a low incidence of hypersensitivity reactions (0.3%) in 14,850 administrations, with no reported deaths, indicating a favorable safety profile.

The risk of nephrogenic systemic fibrosis (NSF) in patients with severe kidney impairment remains uncertain, with an upper bound estimate of 2.8% based on limited data, suggesting more research is needed to fully understand this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events to the Gadolinium-based Contrast Agent Gadoxetic Acid: Systematic Review and Meta-Analysis. Schieda, N., van der Pol, CB., Walker, D., et al.[2020]

Gadolinium-based MRI contrast agents, once thought safe, have been linked to serious complications like acute renal failure and nephrogenic systemic fibrosis in patients with end-stage renal disease (ESRD), leading to restrictions on their use in these high-risk groups.

The editorial emphasizes the need for careful monitoring and documentation of adverse events related to Gad-CAs, as well as collaboration among medical professionals to manage and mitigate risks associated with their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good MRI images: to Gad or not to Gad? Steen, H., Schwenger, V.[2019]

Gadolinium-based contrast agents are generally safe at recommended doses, but there is a growing concern about their association with nephrogenic systemic fibrosis (NSF), which requires radiologists to be aware of potential side effects.

Understanding the biochemical properties of Gd-chelates is crucial for radiologists, as it helps in recognizing the mechanisms behind NSF and managing patient safety effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biochemical safety profiles of gadolinium-based extracellular contrast agents and nephrogenic systemic fibrosis. Ersoy, H., Rybicki, FJ.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Comparison of Autofluorescence With Near-Infrared Fluorescence Imaging Between Primary and Secondary Hyperparathyroidism. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Parathyroid identification during thyroid and parathyroid operations: A pilot study evaluating a novel low cost autofluorescence based device. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Autofluorescence imaging of parathyroid glands: An assessment of potential indications. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Real-time localization of the parathyroid gland in surgical field using Raspberry Pi during thyroidectomy: a preliminary report. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

A coaxial excitation, dual-red-green-blue/near-infrared paired imaging system toward computer-aided detection of parathyroid glands in situ and ex vivo. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Potential Systemic Adverse Events Related to Fluorescein Angiography in Pediatric Patients. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse Events to the Gadolinium-based Contrast Agent Gadoxetic Acid: Systematic Review and Meta-Analysis. [2020]

8. Germany pubmed.ncbi.nlm.nih.gov

Good MRI images: to Gad or not to Gad? [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Iodinated Contrast Media-Induced Thyroid Dysfunction in Euthyroid Nodular Goiter Patients. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Biochemical safety profiles of gadolinium-based extracellular contrast agents and nephrogenic systemic fibrosis. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

Phase-sensitive fluorescence detector for parathyroid glands during thyroidectomy: A preliminary report. [2021]

12. United States pubmed.ncbi.nlm.nih.gov

Ex vivo hypercellular parathyroid gland differentiation using dynamic optical contrast imaging (DOCI). [2022]