N/A
N=160
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy
Parathyroid Adenoma · Parathyroid Neoplasms · Parathyroid Hyperplasia · Parathyroid Cancer · Hypercalcemia
Bottom Line
View on ClinicalTrials.gov: NCT04299425 ↗Enrolled (actual)
160
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Average Number of Parathyroid Glands Identified With High Confidence Per Patient — 3.1; 2.7 parathyroid glands — p=0.04
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NIRAF Detection Technology (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vanderbilt-Ingram Cancer Center
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Number of Parathyroid Glands Identified With High Confidence Per Patient |
3.1; 2.7 | 0.04 sig |
| SECONDARY Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy). |
0; 1 | 1.0 |
| SECONDARY Number of Frozen Sections Sent for Analysis |
13; 45 | — |
| SECONDARY Duration of Parathyroidectomy (PTx) Procedure |
89.3; 95.5 | 0.55 |
| SECONDARY Number of Participants Stratified by Duration of Hospital Stay |
64; 66; 14; 14; 2; 0 | 0.36 |
| SECONDARY Number of 'False Positive' Tissues Excised by Surgeon |
19 | — |
| SECONDARY Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure |
0; 1 | — |
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 device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy.
- Patients with secondary or tertiary hyperparathyroidism.
Data sourced from ClinicalTrials.gov (NCT04299425). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.