What side effects are associated with this type of intervention?

The most common treatments for thyroid cancer include total thyroidectomy, radioactive iodine therapy, and levothyroxine therapy. Total thyroidectomy can lead to complications such as hypoparathyroidism, recurrent laryngeal nerve injury, and infection. Radioactive iodine therapy may cause dry mouth, altered taste, and an increased risk of secondary malignancies. Levothyroxine therapy, used to suppress TSH, can result in symptoms of hyperthyroidism if over-replaced, such as palpitations, weight loss, and osteoporosis. Near infrared autofluorescence (NIRAF) detection, used during thyroidectomy to identify parathyroid glands, aims to reduce the risk of hypoparathyroidism by preserving parathyroid tissue.

What prior FDA approvals exist?

The provided context does not mention specific FDA-approved treatments for thyroid cancer that use near infrared autofluorescence detection like the PTeye device. However, it does discuss the use of radioactive iodine therapy and levothyroxine for managing thyroid cancer, particularly in pediatric patients. Radioactive iodine therapy is commonly used for intermediate- or high-risk patients to reduce recurrence rates and improve post-treatment surveillance. Levothyroxine is used to maintain appropriate thyroid-stimulating hormone (TSH) levels post-thyroidectomy. These treatments are well-established and FDA-approved for managing thyroid cancer.

What other types of research exist?

A promising, novel alternative to PTeye for thyroid cancer patients in 2024 is the use of indocyanine green (ICG) fluorescence with Firefly technology during robotic thyroidectomy. This method aids in the intraoperative localization of parathyroid glands, potentially improving surgical outcomes.

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Procedure

NIRAF Detection for Thyroid Surgery

N/A

Waitlist Available

Research Sponsored by Medical College of Wisconsin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within 24 hours of surgery

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if using a special light device called PTeye during thyroid surgery helps doctors see and protect important glands, reducing complications like low calcium levels.

Who is the study for?

This trial is for patients who are set to undergo a complete thyroid removal surgery, with or without lymph node dissection. It's not for those who only need part of their thyroid removed, have parathyroid disease, or find an enlarged parathyroid during surgery.

What is being tested?

The study tests NIRAF Detection Technology using the 'Parathyroid Eye (PTeye)' device to see if it helps surgeons better identify parathyroid glands during total thyroidectomy compared to surgeries where this technology isn't used.

What are the potential side effects?

Since the intervention involves a detection device rather than a drug, traditional side effects aren't applicable. However, there may be risks associated with potential misidentification of glands leading to surgical complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediate (during total thyroidectomy)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediate (during total thyroidectomy)

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate (during total thyroidectomy) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Postoperative hypoparathyroidism/hypocalcemia (Immediate)

Hypocalcemia

Secondary study objectives

Calcium

Number of auto-transplanted parathyroid glands

Number of doctor visits/emergency department visits or hospital admissions

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: NIRAF Detection Technology (+)Experimental Treatment1 Intervention

Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).

Group II: NIRAF Detection Technology (-)Active Control1 Intervention

Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NIRAF Detection Technology

2020

N/A

~320

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for thyroid cancer include surgery, radioactive iodine therapy, and thyroid hormone therapy. Surgery, often a total thyroidectomy, involves the removal of the thyroid gland and is crucial for eliminating the primary tumor. Radioactive iodine therapy targets and destroys any remaining thyroid tissue or metastatic cells by taking advantage of the thyroid cells' natural ability to absorb iodine. Thyroid hormone therapy, typically with levothyroxine, is used postoperatively to replace normal hormone production and suppress the growth of any residual cancer cells. The use of Near Infrared Autofluorescence Detection (NIRAF) during surgery, such as with the PTeye device, helps in accurately identifying parathyroid glands, thereby reducing the risk of inadvertent damage and subsequent complications like hypoparathyroidism. These treatments are essential for effectively managing thyroid cancer, minimizing recurrence, and ensuring better patient outcomes.