Status:
COMPLETED
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Parathyroid Adenoma
Parathyroid Neoplasms
Eligibility:
All Genders
18-99 years
Phase:
NA
Brief Summary
This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared devic...
Detailed Description
Inability of the surgeon to identify or localize the diseased PG can occur in 5 - 10% of cases resulting in failed parathyroidectomies (PTx). As a result, persistent hyperparathyroidism can occur in t...
Eligibility Criteria
Inclusion
- All primary hyperparathyroidism patients eligible for parathyroidectomy (PTx). Both bilateral and focused mode of PTx will be considered for this study, based on the surgeon's preference.
- Re-operative primary hyperparathyroidism patients who have undergone a failed prior PTx.
Exclusion
- Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy.
- Patients with secondary or tertiary hyperparathyroidism.
Key Trial Info
Start Date :
March 13 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04299425
Start Date
March 13 2020
End Date
March 3 2023
Last Update
May 13 2024
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212