Fluorescence Imaging of the Parathyroid Glands of Children

Trial Title: Fluorescence Imaging of the Parathyroid Glands of Children

NCT ID: NCT05917067

Condition: Childhood Thyroid Gland Carcinoma
Thyroid Diseases

Conditions: Official terms:
Thyroid Neoplasms
Thyroid Diseases
Parathyroid Hormone

Conditions: Keywords:
Indocyanine Green
ICG-fluorescence angiography
Autofluorescence
Children

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Diagnostic Test
Intervention name: Fluorescence imaging of the parathyroid glands of children
Description: 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.
Arm group label: Children (<18 years) that will undergo total thyroidectomy for any indication

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.

Criteria for eligibility:

Study pop:
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.

Sampling method: Probability Sample
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

Gender: All

Minimum age: N/A

Maximum age: 18 Years

Healthy volunteers: No

Locations:

Facility:
Name: Amsterdam UMC - Emma Children's Hospital

Address:
City: Amsterdam
Country: Netherlands

Status: Recruiting

Facility:
Name: UMC Groningen

Address:
City: Groningen
Country: Netherlands

Status: Recruiting

Facility:
Name: UMC Utrecht

Address:
City: Utrecht
Country: Netherlands

Status: Recruiting

Start date: September 1, 2023

Completion date: October 2024

Lead sponsor:
Agency: Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
Agency class: Other

Collaborator:
Agency: Stichting Kinderen Kankervrij (KiKa)
Agency class: Other

Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05917067
https://www.kika.nl/onderzoeken-kinderkanker/minder-bijwerkingen-van-operatie-bij-kinderen-met-schildklierkanker