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NCT05917067Completed

Fluorescence Imaging of the Parathyroid Glands of Children

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

Source: ClinicalTrials.gov · Last updated 30 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
23 (actual)
First submitted
13 Jun 2023
Start date
1 Sept 2023
Primary completion date
1 Oct 2024
Lead sponsor
Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
NCT number
NCT05917067

What you commit to

  • Study type: Observational
  • Participants enrolled: 23
  • From 1 Sept 2023 to the primary completion date, 1 Oct 2024
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with known allergy to ICG or iodinated contrast

Lab values

  • 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).

Other

  • Pregnancy or breastfeeding
  • Patients with severe liver dysfunction
  • Preterm neonates
  • Newborn infants with an indication for exchange transfusion for severe neonatal hyperbilirubinemia

Who the study is looking for

  • 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)

Age in the registry: - to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Amsterdam UMC - Emma Children's Hospital
Coordinator of this site? Confirm its status
AmsterdamNetherlandsUnknown status
UMC Groningen
Coordinator of this site? Confirm its status
GroningenNetherlandsUnknown status
UMC Utrecht
Coordinator of this site? Confirm its status
UtrechtNetherlandsUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.