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Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy

NCT04424485 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-06-11

No results posted yet for this study

Summary

Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) imaging has been recently introduced, and has been suggested as a useful tool for the identification and preservation of the parathyroid glands (PGs) during total thyroidectomy (TT). ICG can also be used for sentinel lymph node (SLN) biopsy to predict the micrometastases in central lymph nodes (CLN) in thyroid carcinoma, and central lymph node dissection can reduce local recurrence.

Conditions

  • Thyroid Cancer
  • Thyroid Carcinoma, Papillary
  • Thyroid Metastases
  • Thyroid Neoplasms
  • Sentinel Lymph Node
  • Lymph Node Metastases

Interventions

PROCEDURE

Total thyroidectomy (TT)

Standard TT procedure for thyroid carcinoma, for both groups

PROCEDURE

Central lymph node dissection (CLND)

Standard CLND for thyroid carcinoma, for both groups

DIAGNOSTIC_TEST

Sentinel lymph node (SLN) bopsy

Intrathyroidal injection of ICG for SL biopsy, for only experimental group

DIAGNOSTIC_TEST

Identification of parathyroid glands (PGs)

Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group

Sponsors & Collaborators

  • Umraniye Education and Research Hospital

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • Turkey (Türkiye)

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04424485 on ClinicalTrials.gov