Clinical trial NCT05917067: Fluorescence Imaging of the Parathyroid Glands of Children
Official title: Fluorescence Imaging for the Detection and Perfusion of the Parathyroid Glands of Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Childhood Thyroid Gland Carcinoma
Thyroid Diseases
Keywords: Indocyanine Green
ICG-fluorescence angiography
Autofluorescence
Children
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2023-06-23
Enrollment: 23
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number and location of autofluorescent parathyroid glands
timeFrame: During thyroid surgery
measure: Quantification of the fluorescent signal of ICG
timeFrame: During thyroid surgery
measure: Postoperative hypocalcemia
timeFrame: Postoperative day 1-3 and first out-patient clinic visit (between day 1 and day 10 postoperative)
Secondary outcomes:
Other outcomes:
measure: Postoperative calcium supplementation
timeFrame: Postoperative day 1-3 and first out-patient clinic visit (between day 1 and day 10 postoperative)
measure: Total duration of the operation
timeFrame: Day of the operation
measure: (postoperative) complications, following the Clavien-Dindo classification
timeFrame: During thyroid surgery and day 1-3 till and first out-patient clinic visit (between day 1 and day 10 postoperative)
measure: Need for autotransplantation of the parathyroid glands
timeFrame: During thyroid surgery
Locations:
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC - Emma Children's Hospital
city: Groningen
country: Netherlands
facility: UMC Groningen
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: Amsterdam UMC - Emma Children's Hospital
name: Joep Derikx, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: