Fluorescence Imaging of the Parathyroid Glands of Children (FLUOPATCH)

Fluorescence Imaging for the Detection and Perfusion of the Parathyroid Glands of Children

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.

Study Overview

• Status: Completed
• Conditions: Thyroid Diseases; Childhood Thyroid Gland Carcinoma
• Intervention / Treatment: Diagnostic test: Fluorescence imaging of the parathyroid glands of children

Detailed Description

Background:

Children with thyroid cancer have excellent survival rates. However, postoperative hypocalcemia, due to inadvertent excision of the parathyroid glands or damage to their vasculature during thyroid surgery, is a severe complication which occurs in 24% - 67% of the children with thyroid cancer and causes lifelong reduced quality of life and increased morbidity rates. In adults, intraoperative identification of the parathyroid glands with autofluorescence and assessment of their perfusion using quantified ICG-fluorescence angiography has shown to reduce postoperative hypocalcemia. However, in children no studies regarding quantified fluorescence of the parathyroid glands have been conducted. There is a clear need for surgical techniques to identify and preserve the parathyroid glands during thyroid surgery in children.

Therefore, the aim of this study is to develop a standardized imaging workflow model for autofluorescence and quantified ICG-angiography of the parathyroid glands in children. This workflow model can be the first step in reducing the rate of postoperative hypocalcemia in children.

Study design:

This will be a prospective, observational, multicenter, feasibility study. The aim is to generate the patterns of intraoperative autofluorescence and quantified ICG-fluorescence angiography of the parathyroid glands in children, resulting in a user-independent, standardized imaging workflow model for autofluorescence and quantified ICG-angiography of the parathyroid glands of children.

• Study Type: Observational
• Enrollment (Actual): 23

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Amsterdam UMC - Emma Children's Hospital
  • Groningen, Netherlands
    • UMC Groningen
  • Utrecht, Netherlands
    • UMC Utrecht

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. 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).
2. Patients with known allergy to ICG or iodinated contrast
3. Pregnancy or breastfeeding
4. Patients with severe liver dysfunction
5. Preterm neonates
6. Newborn infants with an indication for exchange transfusion for severe neonatal hyperbilirubinemia

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Diagnostic test: Fluorescence imaging of the parathyroid glands of children; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative calcium supplementation	Need for (extra) 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	Total duration of the operation in minutes	Day of the operation
(postoperative) complications, following the Clavien-Dindo classification	Any (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)
Need for autotransplantation of the parathyroid glands	Need for autotransplantation of the parathyroid glands by visual assessment (non-fluorescence) of the surgeon	During thyroid surgery

Collaborators and Investigators

• Sponsor: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
• Collaborators: Stichting Kinderen Kankervrij (KiKa)
• Investigators: Principal Investigator: Joep Derikx, MD, PhD, Amsterdam UMC - Emma Children's Hospital

Publications and helpful links

Helpful Links

• KiKa funding page for the present study

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 22, 2023
• First Posted (Actual): June 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Children; Indocyanine Green; Autofluorescence; ICG-fluorescence angiography
• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Thyroid Diseases; Thyroid Neoplasms; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Parathyroid Hormone
• Other Study ID Numbers: 2023.0263

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Request for data sharing will be considered by the project leaders upon written request. Deidentified participant data will be made available after receipt of a written proposal and a signed data sharing agreement. Furthermore, an amendment will be handed in to the MEC for ethical approval before starting this additional research.
• IPD Sharing Time Frame: The study protocol will be published in a international, peer-reviewed journal with open acces, during the study period.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No