Fluorescence Imaging of the Parathyroid Glands of Children

Thyroid Diseases Clinical Trial

— FLUOPATCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05917067
• Other study ID #: 2023.0263
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: October 2024

Study information

• Verified date: September 2023
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: Daniël van de Berg, MD
• Phone: +31651001594
• Email: d.j.vandeberg[@]amsterdamumc.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC - Emma Children's Hospital	Amsterdam
Netherlands	UMC Groningen	Groningen
Netherlands	UMC Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)	Stichting Kinderen Kankervrij (KiKa)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Total duration of the operation	Total duration of the operation in minutes	Day of the operation
Other	(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)
Other	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
Primary	Number and location of autofluorescent parathyroid glands	Number and location of autofluorescent parathyroid glands	During thyroid surgery
Primary	Quantification of the fluorescent signal of ICG	Quantification of the fluorescent signal of ICG	During thyroid surgery
Primary	Postoperative hypocalcemia	Postoperative hypocalcemia	Postoperative day 1-3 and first out-patient clinic visit (between day 1 and day 10 postoperative)

External Links

•   KiKa funding page for the present study