Intraoperative Identification of Parathyroid Adenomas Using PTeye™ and FLUOBEAM® LX: a Prospective Cohort Study

NCT06788223 | Active Not Recruiting DMC

• 1 other identifier: PTeye
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to evaluate the efficacy of PTeyeTM device to confirm a parathyroid adenoma on a visually suspected tissue in comparison with the FLUOBEAM®LX device. The main questions it aims to answer is: Is the PTeyeTM device effective in identifying the presence of a parathyroid adenoma? Which autofluorecence device (PTeye or FLUOBEAM®LX) is more effective in confirming the presence of a parathyroid adenoma? Participants will undergo parathyroidectomy under general anesthesia. During the procedure visually suspected tissue for parathyroid adenoma will be evaluated with the PTeye or FLUOBEAM®LX device for the presence of an adenoma (minute 0). Tissue will be reevaluated on minutes 1, 3, and 5 and before excision.

Conditions

Primary Hyperparathyroidism Due to Adenoma

Outcome Measures

Primary Outcomes (1)

• Identification of the parathyroid adenoma

  The percentage of adenomas identified by each device is assessed after intraoperative identification of parathyroid adenomas and before tissue dissection (minute 0). The same percentage will be re-evaluated on minutes 1, 3 and 5 during tissue dissection and before adenoma excision.

  The minute of the identification of the parathyroid adenoma (minute 0). Reevaluation in minutes 1, 3, and 5 during tissue dissection and before excision.

Study Arms (2)

PTeye

Localizing Parathyroid adenoma with the PTeye device during parathyroidectomy

Device: Parathyroidectomy

Fluobeam

Localizing Parathyroid adenoma with the Fluobeam/ Fluoptics device

Device: Parathyroidectomy

Interventions

Parathyroidectomy DEVICE

Parathyroidectomy under general anesthesia

Fluobeam; PTeye

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary hyperparathyroidism and parathyroid adenoma, fulfilling the AAES guidelines indications for parathyroidectomy.

You may qualify if:

• \- Patients with Primary parathyroidism with parathyroid adenoma

You may not qualify if:

• Parathyroid Hyperplasia,
• Secondary hyperparathyroidism

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Parathyroid Neoplasms

Interventions

Parathyroidectomy

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases

Intervention Hierarchy (Ancestors)

Endocrine Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 23, 2025
• Study Start: November 1, 2024
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: January 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

GR (1)