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NIRAF Detection Technology

NIRAF Detection for Parathyroid Disorders (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 0-72 hours after ptx procedure.
Awards & highlights

NIRAF Trial Summary

This trial found that using NIRAF detection with PTeye during PTx was not associated with significantly greater risk-benefits or outcomes compared to not using NIRAF detection with PTeye during PTx.

Eligible Conditions
  • Primary Hyperparathyroidism
  • Parathyroid Adenomas
  • Parathyroid Tumors
  • Parathyroid Hyperplasia
  • Parathyroid Cancer
  • Hypercalcemia

NIRAF Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5-14 days after ptx procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5-14 days after ptx 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
Persistent hyperparathyroidism (Immediate)
Persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy)
Persistent hyperparathyroidism or hypercalcemia (transient)
Secondary outcome measures
Parathyroidectomy
Duration taken for intraoperative parathyroid hormone (PTH) to normalize
Duration taken to identify first parathyroid gland
+10 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 parathyroidectomy (PTx).
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 parathyroidectomy (PTx).
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
13,654 Previous Clinical Trials
40,932,993 Total Patients Enrolled
Carmen C Solorzano, MD, FACSPrincipal InvestigatorVanderbilt University Medical Center
1 Previous Clinical Trials
160 Total Patients Enrolled

Media Library

PTeye (NIRAF Detection Technology) Clinical Trial Eligibility Overview. Trial Name: NCT04299425 — N/A
Primary Hyperparathyroidism Research Study Groups: NIRAF Detection Technology +, NIRAF Detection Technology -
Primary Hyperparathyroidism Clinical Trial 2023: PTeye Highlights & Side Effects. Trial Name: NCT04299425 — N/A
PTeye (NIRAF Detection Technology) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04299425 — N/A

Frequently Asked Questions

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

Does my profile meet the requirements to participate in this research?

"This trial is open to patients with parathyroid adenomas, aged 18 or older and below 99 years old. The study requires the participation of around 160 volunteers."

Answered by AI

What are the primary goals that this experiment seeks to accomplish?

"This medical trial, which will be carried out over a given duration of time, seeks to resolve Persistent hyperparathyroidism or hypercalcemia following parathyroidectomy (PTx). Secondary objectives include determining the Number of 'false positive' tissues excised by surgeon, Duration taken for intraoperative parathyroid hormone (PTH) to normalize and the Number of diseased parathyroid glands identified versus preoperatively localized glands."

Answered by AI

Are applicants aged 40 and over accepted for this exploratory research?

"Candidates aged 18 and younger than 99 are welcome to take part in this medical research."

Answered by AI

Is this experimental therapy still available to participants?

"Affirmative. Clinicaltrials.gov shows that this study is actively looking for participants to join; the trial was first introduced on March 13th 2020 and recently updated on April 11th 2022. The research necessitates 160 patients from a single medical site."

Answered by AI

Can you elaborate on the total number of participants who have signed up for this clinical trial?

"Affirmative. The records on clinicaltrials.gov indicates that, since its first posting in March 2020, this medical research is still recruiting participants from a single site for a total of 160 patients."

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