Childhood Thyroid Gland CarcinomaFLUOPATCHNCT05917067
Fluorescence Imaging of the Parathyroid Glands of Children
An observational study of Childhood Thyroid Gland Carcinoma and Thyroid Diseases, run by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) at 3 sites in Netherlands.
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Childhood Thyroid Gland Carcinoma, Thyroid Diseases
- What is being tested?
- Fluorescence imaging of the parathyroid glands of children
- Type of treatment
- Injection or infusion
- How many people
- 23 participants
- Where
- 3 sitesNetherlands
- Study dates
- 1 Sep 2023to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Who cannot join
- 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).
- Patients with known allergy to ICG or iodinated contrast
- Pregnancy or breastfeeding
- Patients with severe liver dysfunction
- Preterm neonates
- Newborn infants with an indication for exchange transfusion for severe neonatal hyperbilirubinemia
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Amsterdam UMC - Emma Children's Hospital
Amsterdam
UMC Groningen
Groningen
UMC Utrecht
Utrecht
About this study
Official title: Fluorescence Imaging for the Detection and Perfusion of the Parathyroid Glands of Children
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.
Read the 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.
- Being tested
- Fluorescence imaging of the parathyroid glands of children
- Keywords
- Indocyanine Green, ICG-fluorescence angiography, Autofluorescence, Children
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluorescence imaging of the parathyroid glands of childrenDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Children (<18 years) that will undergo total thyroidectomy for any indication | Not described Receives: Diagnostic Test: Fluorescence imaging of the parathyroid glands of children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and location of autofluorescent parathyroid glands
Number and location of autofluorescent parathyroid glands
Measured: During thyroid surgery
Quantification of the fluorescent signal of ICG
Quantification of the fluorescent signal of ICG
Measured: During thyroid surgery
Postoperative hypocalcemia
Postoperative hypocalcemia
Measured: Postoperative day 1-3 and first out-patient clinic visit (between day 1 and day 10 postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start1 Sep 2023
- Primary completion1 Oct 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Thyroid Gland CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniël van de Berg, MD, Amsterdam UMC, location VUmc
- Investigators
- Joep Derikx, MD, PhD, Principal investigator, Amsterdam UMC - Emma Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05917067
- Sponsor's protocol ID
- 2023.0263
- Acronym
- FLUOPATCH
- Status last verified
- Jan 2025
- First submitted
- 13 Jun 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fluorescence Imaging for the Detection and Perfusion of the Parathyroid Glands of Children
- ClinicalTrials.gov ID
- NCT05917067
- Acronym / sponsor ID
- FLUOPATCH / 2023.0263
- Keywords
- Indocyanine Green, ICG-fluorescence angiography, Autofluorescence, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC)University, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children (<18 years) that will undergo total thyroidectomy for any indication | – | Diagnostic Test: Fluorescence imaging of the parathyroid glands of children |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (6 listed)
- 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).
- Patients with known allergy to ICG or iodinated contrast
- Pregnancy or breastfeeding
- Patients with severe liver dysfunction
- Preterm neonates
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluorescence imaging of the parathyroid glands of childrenPatients 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. | Diagnostic test | Children (<18 years) that will undergo total thyroidectomy for any indication |
Primary outcome
Number and location of autofluorescent parathyroid glands
Time frame: During thyroid surgery
Number and location of autofluorescent parathyroid glands
Quantification of the fluorescent signal of ICG
Time frame: During thyroid surgery
Quantification of the fluorescent signal of ICG
Postoperative hypocalcemia
Time frame: Postoperative day 1-3 and first out-patient clinic visit (between day 1 and day 10 postoperative)
Postoperative hypocalcemia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- KiKa funding page for the present studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joep Derikx, MD, PhD principal investigator
Amsterdam UMC - Emma Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Thyroid Gland Carcinoma and Thyroid Diseases, run by Amsterdam University Medical Centers (UMC), Location Academic Medical Center (AMC) at 3 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and location of autofluorescent parathyroid glands (time frame: During thyroid surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.