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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new hand-held imaging device to help surgeons locate the parathyroid glands during thyroid surgery. Accurate identification of these glands can prevent complications such as low calcium levels, which might require further treatment or longer hospital stays. The trial uses parathyroid auto-fluorescence imaging, a special technique to highlight the glands. Participants needed for this trial are those requiring thyroid surgery due to conditions like thyroid tumors. Individuals advised to undergo thyroid surgery, with plans to remove part of the parathyroid glands, might be suitable candidates. As a Phase 1 trial, this research aims to understand how the imaging device functions in people, offering participants the opportunity to be among the first to benefit from this innovative technology.

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 prior data suggests that this hand-held imaging device is safe for identifying parathyroid glands?

Research has shown that parathyroid auto-fluorescence imaging is a promising and safe tool for thyroid and parathyroid surgeries. Studies have found it to be a simple and easily accessible method that helps surgeons identify the parathyroid glands more accurately, reducing the risk of accidentally removing or damaging them. This can prevent complications like low calcium levels after surgery.

While other tissues, such as thyroid nodules or fat, might occasionally appear similar under this imaging, these issues are minor in terms of safety. Overall, no major side effects have been reported from using this technique, indicating that parathyroid auto-fluorescence imaging is well-tolerated and safe for patients undergoing these surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about parathyroid auto-fluorescence imaging because it offers a unique way to enhance thyroid surgery outcomes. Unlike traditional methods that rely on visual identification, this technique uses the natural glow of parathyroid tissue to help surgeons distinguish it more accurately during operations. This could significantly reduce the risk of accidental damage to the parathyroid glands, which is a common complication in thyroid surgeries. By improving surgical precision, this imaging method has the potential to lead to better patient recovery and fewer postoperative complications.

What evidence suggests that this hand-held imaging device is effective for identifying parathyroid glands?

Research has shown that a special imaging technique called parathyroid auto-fluorescence, studied in this trial, can help doctors locate parathyroid glands more easily during surgery. One study increased the success rate of finding these glands to 86.4%, compared to 70.6% without it. Another study found that surgeons identified 17.9% more parathyroid glands per patient using this technology. This helps prevent the accidental removal of these glands, which can cause complications. Overall, this imaging technique appears promising in making thyroid surgeries safer by protecting the parathyroid glands. ^{2 3 6 7 8}

Who Is on the Research Team?

Kaitlyn Frazier, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

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Fluorescent imaging significantly improved PG identification rates (86.4% vs 70.6%, P < .0001) and reduced incidental parathyroidectomy (5.3% vs ...

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False positives have been reported to occur with colloid thyroid nodules, brown fat and cancer cells as they may have endogenous fluorophores.