Gland and Hormone Related Diseases

All Conditions

Neoplasms

Thyroid Diseases

Carcinoma

Thyroid Neoplasms

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

All Drugs and Chemicals

Bone Density Conservation Agents

Parathyroid Hormone

Hormones

Calcium

Calcium, Dietary

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.

Fluorescence imaging of the parathyroid glands of children

Daniël van de Berg, MD

Joep Derikx, MD, PhD

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.

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.

Fluorescence Imaging of the Parathyroid Glands of Children

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

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.

Need for (extra) postoperative calcium supplementation

Total duration of the operation in minutes

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

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

Number and location of autofluorescent parathyroid glands

Quantification of the fluorescent signal of ICG

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Fluorescence Imaging of the Parathyroid Glands of Children	NCT05917067	Childhood Thyro... Thyroid Disease...	Fluorescence im...	- 18 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Fluorescence Imaging of the Parathyroid Glands of Children	NCT05917067	Childhood Thyro... Thyroid Disease...	Fluorescence im...	- 18 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Spots Global Cancer Trial Database for fluorescence imaging of the parathyroid glands of children