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NCT Number: NCT05917067

Fluorescence Imaging 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.

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Key information

Conditions

Childhood Thyroid Gland Carcinoma Endocrine System Diseases Thyroid Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC - Emma Children's Hospital, Amsterdam, Netherlands

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. Number and location of autofluorescent parathyroid glands

    Time frame: During thyroid surgery

    Number and location of autofluorescent parathyroid glands

  2. Quantification of the fluorescent signal of ICG

    Time frame: During thyroid surgery

    Quantification of the fluorescent signal of ICG

  3. Postoperative hypocalcemia

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

    Postoperative hypocalcemia

Other outcomes

  1. Postoperative calcium supplementation

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

    Need for (extra) postoperative calcium supplementation

  2. Total duration of the operation

    Time frame: Day of the operation

    Total duration of the operation in minutes

  3. (postoperative) complications, following the Clavien-Dindo classification

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

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

  4. Need for autotransplantation of the parathyroid glands

    Time frame: During thyroid surgery

    Need for autotransplantation of the parathyroid glands by visual assessment (non-fluorescence) of the surgeon

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: FLUOPATCH

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 23, 2023
Registry last updated
Jan 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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