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NIRAF Detection for Thyroid Disease (NIRAF Trial)

N/A
Waitlist Available
Led By Carmen C Solorzano, MD, FACS
Research Sponsored by Vanderbilt-Ingram Cancer Center
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 after total thyroidectomy.
Awards & highlights

NIRAF Trial Summary

This trial found that the use of NIRAF detection with PTeye during TTx was associated with a significantly lower risk of postoperative hypoparathyroidism.

Eligible Conditions
  • Thyroid Cancer
  • Hypoparathyroidism

NIRAF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediate. during total thyroidectomy procedure.
This trial's timeline: 3 weeks for screening, Varies for treatment, and immediate. during total thyroidectomy procedure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Hypocalcemia
Postoperative hypoparathyroidism/hypocalcemia (Permanent)
Hypocalcemia
Secondary outcome measures
Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery
Number of auto-transplanted parathyroid glands
Number of doctor visits/emergency department visits or hospital admissions
+5 more

NIRAF 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 with the naked eye of the surgeon 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
~160

Find a Location

Who is running the clinical trial?

Vanderbilt-Ingram Cancer CenterLead Sponsor
213 Previous Clinical Trials
60,773 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,329 Total Patients Enrolled
Carmen C Solorzano, MD, FACSPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

NIRAF Detection Technology Clinical Trial Eligibility Overview. Trial Name: NCT04281875 — N/A
Thyroid Cancer Research Study Groups: NIRAF Detection Technology +, NIRAF Detection Technology -
Thyroid Cancer Clinical Trial 2023: NIRAF Detection Technology Highlights & Side Effects. Trial Name: NCT04281875 — N/A
NIRAF Detection Technology 2023 Treatment Timeline for Medical Study. Trial Name: NCT04281875 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients are participating in this research study?

"Affirmative. The information available on clinicaltrials.gov confirms that recruitment for this medical trial is ongoing; the initial post was made on March 16th 2020 and it has been updated as recently as April 11th 2022, with a requirement of 160 patients from 1 site."

Answered by AI

What are the main aims of this investigation?

"The primary assessment of this study will evaluate incidences of postoperative hypoparathyroidism/hypocalcemia within 24 hours after total thyroidectomy. As secondary outcomes, investigators are looking to measure the overall number of parathyroid glands identified via naked eye and near-infrared autofluorescence (NIRAF), auto-transplanted parathyroid glands if accidentally excised or devascularized, and frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue."

Answered by AI

Does the eligibility criterion for this experiment include elderly participants?

"This medical trial welcomes individuals aged 18 and over, up to the age of 99."

Answered by AI

Could I fulfill the criteria to join this research endeavor?

"This research project is accepting 160 individuals with thyroid adenoma from 18 to 99 years of age. In particular, the eligibility criteria are as follows: (i) All patients fit for total thyroidectomy (TTx), either with or without lymph node dissection; this includes those who previously had a neck exploration due to parathyroid issues but still have an intact thyroid. and (ii) Everyone undergoing completion thyroidectomy."

Answered by AI

Are there still opportunities for individuals to join this clinical experiment?

"As documented on clinicaltrials.gov, this research initiative is actively recruiting individuals to participate. It was initially posted in March of 2020, with updates done as recently as April 2022."

Answered by AI
Recent research and studies
~31 spots leftby Apr 2025