Fluorescence Imaging of the Parathyroid Glands of Children

NCT05917067 | Completed

• 1 other identifier: 2023.0263
• Study Type: observational
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

The aim of this study is to develop a standardized and user-independent imaging workflow model for autofluorescence and quantified fluorescence angiography with Indocyanine Green (ICG) of the parathyroid glands of children. For this purpose, all pediatric patients will undergo thyroid surgery with the use of autofluorescence and quantified ICG-fluorescence. This study could be the first step in reducing the rate of postoperative hypocalcemia in children, by using fluorescence angiography during pediatric thyroid surgery.

Conditions

Childhood Thyroid Gland Carcinoma; Thyroid Diseases

Keywords

Indocyanine Green; ICG-fluorescence angiography; Autofluorescence; Children

Outcome Measures

Primary Outcomes (3)

• Number and location of autofluorescent parathyroid glands

  Number and location of autofluorescent parathyroid glands

  During thyroid surgery

• Quantification of the fluorescent signal of ICG

  Quantification of the fluorescent signal of ICG

  During thyroid surgery

• Postoperative hypocalcemia

  Postoperative hypocalcemia

  Postoperative day 1-3 and first out-patient clinic visit (between day 1 and day 10 postoperative)

Other Outcomes (4)

• Postoperative calcium supplementation

  Postoperative day 1-3 and first out-patient clinic visit (between day 1 and day 10 postoperative)

• Total duration of the operation

  Day of the operation

• (postoperative) complications, following the Clavien-Dindo classification

  During thyroid surgery and day 1-3 till and first out-patient clinic visit (between day 1 and day 10 postoperative)

Study Arms (1)

Children (<18 years) that will undergo total thyroidectomy for any indication

Diagnostic Test: Fluorescence imaging of the parathyroid glands of children

Interventions

Fluorescence imaging of the parathyroid glands of children DIAGNOSTIC_TEST

Patients that participate in this study will always receive standard care. For the purpose of this study, the camera settings (i.e. camera distance to the operating field, switching of OR-lights, and angle of the camera on the operating field) and ICG-protocol (i.e. dose, injection speed) will be standardized among the participating centers in order to generate an homogeneous data set for quantification of the fluorescence signal intensity.

Children (<18 years) that will undergo total thyroidectomy for any indication

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients under 18 years old that will undergo total thyroidectomy for any indication or lobectomy for the suspicion of a malignancy will be checked for the inclusion and excusion criteria. If eligible, patients will be asked for written informed consent.

You may qualify if:

• Patients \<18 years
• Patients undergoing total thyroidectomy (for any indication)
• Patients undergoing lobectomy for the suspicion of a malignancy, with a subsequent completion thyroidectomy
• Written informed consent (from parents/caregivers, patients or both, see chapter 6.0)

You may not qualify if:

• Patients with preoperative hypo - or hypercalcemia, treated for hypo- or hypercalcemia, (chronic) renal disease, kidney transplantation or any disorder that requires calcium supplementation (other than standard preoperative calcium supplementation for a total thyroidectomy).
• Patients with known allergy to ICG or iodinated contrast
• Pregnancy or breastfeeding
• Patients with severe liver dysfunction
• Preterm neonates
• Newborn infants with an indication for exchange transfusion for severe neonatal hyperbilirubinemia

Sponsors & Collaborators

• Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC): lead

Study Sites (3)

Amsterdam UMC - Emma Children's Hospital

Amsterdam, Netherlands

Location

UMC Groningen

Groningen, Netherlands

Location

UMC Utrecht

Utrecht, Netherlands

Location

Related Links

• KiKa funding page for the present study

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Joep Derikx, MD, PhD

  Amsterdam UMC - Emma Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 23, 2023
• Study Start: September 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The study protocol will be published in a international, peer-reviewed journal with open acces, during the study period.

Locations

NL (3)