Thyroid DiseaseNCT03012438
NIRF for Parathyroid Visualization: a Pilot Study
A study testing NIRF imaging in thyroid surgery in people with Thyroid Disease, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
During surgery in which the thyroid is removed (thyroidectomy), the identification of parathyroid glands, that should be saved, can be challenging. Therefore, there is need for accurate intraoperative guidance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Disease
- What is being tested?
- NIRF imaging in thyroid surgery
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Mar 2017to 12 Mar 2018
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, aged 18 years and above
- Scheduled for elective total or hemi thyroidectomy
- Normal liver and renal function
- No known hypersensitivity for iodine or ICG
- Able to understand the nature of the study procedures
- Willing to participate and give written informed consent
Who cannot join
- Age < 18 years
- Liver or renal insufficiency
- Known ICG, iodine, penicillin or sulfa hypersensitivity
- Pregnancy or breastfeeding
- Not able to understand the nature of the study procedure
- i.v. heparin injection in the last 24h (LMWH not contraindicated)
- Not willing to participate
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6202
About this study
Official title: The Use of Near-Infrared Fluorescence Imaging in Parathyroid Visualization During Thyroid Surgery: a Pilot Study
During surgery in which the thyroid is removed (thyroidectomy), the identification of parathyroid glands, that should be saved, can be challenging. Therefore, there is need for accurate intraoperative guidance. Earlier animal studies show that the parathyroid glands can be identified by the use of the Near Infrared Fluorescent dye Indocyanine green (ICG).
Our hypothesis is therefore, that the use of ICG-based fluorescence imaging during thyroid surgery will provide real-time intraoperative visualization of the parathyroid glands.
This prospective observational feasibility study aims to evaluate the feasibility of the use of ICG in identifying the parathyroid glands during thyroid surgery. 30 patients (age >18 years) who are already regularly scheduled for thyroid surgery; i.e. patients undergoing total thyroidectomy are suitable for inclusion. In all patients, undergoing total thyroidectomy infrared fluorescence imaging, using a per-operative intravenous injection of 7.5 mg ICG, will be tested on feasibility and imaging characteristics.
Read the detailed description
In this study, the feasibility of the use of NIR fluorescence imaging for the identification of the parathyroid glands during thyroid surgery will be explored.
Per-operatively: The surgery will start as usual. When the surgeon would normally search for the parathyroid glands, 7.5 mg of ICG will be administered intravenously through the infusion in the patients arm. An intravenous administration is chosen because of the minimal invasive nature and results of the described earlier case series in which ICG was also administered via peripheral infusion. Directly after that, the fluorescence system can be switched to fluorescence mode. The surgeon will determine whether the parathyroid glands are visible now. If needed, due to washout, a second dose of 7.5 mg of ICG can be administered. After identification of the parathyroid glands, surgery will continue as in the standard situation, until there is a desire to visualize the parathyroid glands again, then another dose of ICG can be given. Time until first identification of the parathyroid glands and total surgical time will be measured. After complete removal of the thyroid, another 7.5 mg of ICG will be administered intravenously to visualize the vascularization of the parathyroid gland. The intensity will be subjectively scored: 1 parathyroid black after injection of ICG, 2 partially vascularized, or 3 parathyroid is green; well vascularized. The fluorescence system will be used to record the whole procedure. Directly after the procedure the researcher will ask the surgeon whether he or she thinks the technique is feasible.
Postoperatively: As in standard care, after thyroid surgery, the serum calcium levels will be determined. Low calcium levels can indicate misidentification of parathyroid glands. These calcium levels are determined only in patients after total thyroidectomy on day 1, 2 and after two weeks. Also TSH will be determined after two weeks as in standard care. The thyroid specimen will be send to pathology. In the specimen, the pathologist will search for parathyroid glands, as is standard care. Furthermore, video recordings will be analyzed, quantifying the fluorescence signal compared to the background: measuring the Target to Background Ratio. Also, in these video recordings the time until visualization of the parathyroid glands will be reassessed by an independent expert.
- Conditions
- Thyroid Disease
- Being tested
- NIRF imaging in thyroid surgery
- Keywords
- Near infrared fluorescence, ICG, Parathyroid gland
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NIRF imaging in thyroid surgeryDevice
Also called Near Infrared Fluorescence Imaging, Indocyanine green
a fluorescence imaging system and 7.5 mg of ICG will be used to visualize the parathyroids glands.
| Study group | Role | What they receive |
|---|---|---|
| NIRF imaging in thyroid surgery | Experimental | 7.5 mg ICG is administered i.v. and the system will be switched to fluorescence mode. If needed, a second dose of 7.5 mg ICG can be administered. After identification of the parathyroid glands, surgery will continue until there is a desire to visualize the parathyroid glands again, another dose of ICG can be given. After complete removal of thyroid, another 7.5 mg of ICG will be given to assess the perfusion of the parathyroid gland. Directly after the procedure the researcher will ask the surgeon whether he/she thinks the technique is feasible.
After surgery, the serum calcium levels will be determined in patients after total thyroidectomy on day 1, 2 and after two weeks. TSH will be determined after 2 weeks. The thyroid specimen will be send to pathology. In the specimen, the pathologist will search for parathyroid glands. Video recordings will be analyzed, quantifying the fluorescence signal compared to the background: measuring the TBR. Receives: Device: NIRF imaging in thyroid surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to identification of parathyroid glans
Can the parathyroid glands be identified earlier with NIRF light? Time until identification in NIRF and white light will be compared.
Measured: during surgery
Secondary outcomes (4)
Total surgical time
Measured: From incision until closure
Histology: are parathyroid glands in the specimen? (as in standard care)
immediately after surgery, the thyroid specimen will be send to the pathology department for histological examination as in standard care, with extra attention on wether there are parathyroid glands in the specimen.
Measured: assessment within 1 week after surgery
Subjective opinion surgeon about the usefulness of the technique
Measured: Immediately after surgery
Intra-operative complications due to the use of the technique
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study start23 Mar 2017
- Primary completion1 Feb 2018
- Study completion12 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseaseStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Bouvy, M.D. Ph.D., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03012438
- Sponsor's protocol ID
- NL57409.068.16
- Status last verified
- Apr 2017
- First submitted
- 3 Jan 2017
- Last updated
- 14 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Near-Infrared Fluorescence Imaging in Parathyroid Visualization During Thyroid Surgery: a Pilot Study
- ClinicalTrials.gov ID
- NCT03012438
- Acronym / sponsor ID
- NL57409.068.16
- Conditions
- Thyroid Disease
- Keywords
- Near infrared fluorescence, ICG, Parathyroid gland
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 23 Mar 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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.
During surgery in which the thyroid is removed (thyroidectomy), the identification of parathyroid glands, that should be saved, can be challenging. Therefore, there is need for accurate intraoperative guidance. Earlier animal studies show that the parathyroid glands can be identified by the use of the Near Infrared Fluorescent dye Indocyanine green (ICG).
Our hypothesis is therefore, that the use of ICG-based fluorescence imaging during thyroid surgery will provide real-time intraoperative visualization of the parathyroid glands.
This prospective observational feasibility study aims to evaluate the feasibility of the use of ICG in identifying the parathyroid glands during thyroid surgery. 30 patients (age >18 years) who are already regularly scheduled for thyroid surgery; i.e. patients undergoing total thyroidectomy are suitable for inclusion. In all patients, undergoing total thyroidectomy infrared fluorescence imaging, using a per-operative intravenous injection of 7.5 mg ICG, will be tested on feasibility and imaging characteristics.
Detailed description
In this study, the feasibility of the use of NIR fluorescence imaging for the identification of the parathyroid glands during thyroid surgery will be explored.
Per-operatively: The surgery will start as usual. When the surgeon would normally search for the parathyroid glands, 7.5 mg of ICG will be administered intravenously through the infusion in the patients arm. An intravenous administration is chosen because of the minimal invasive nature and results of the described earlier case series in which ICG was also administered via peripheral infusion. Directly after that, the fluorescence system can be switched to fluorescence mode. The surgeon will determine whether the parathyroid glands are visible now. If needed, due to washout, a second dose of 7.5 mg of ICG can be administered. After identification of the parathyroid glands, surgery will continue as in the standard situation, until there is a desire to visualize the parathyroid glands again, then another dose of ICG can be given. Time until first identification of the parathyroid glands and total surgical time will be measured. After complete removal of the thyroid, another 7.5 mg of ICG will be administered intravenously to visualize the vascularization of the parathyroid gland. The intensity will be subjectively scored: 1 parathyroid black after injection of ICG, 2 partially vascularized, or 3 parathyroid is green; well vascularized. The fluorescence system will be used to record the whole procedure. Directly after the procedure the researcher will ask the surgeon whether he or she thinks the technique is feasible.
Postoperatively: As in standard care, after thyroid surgery, the serum calcium levels will be determined. Low calcium levels can indicate misidentification of parathyroid glands. These calcium levels are determined only in patients after total thyroidectomy on day 1, 2 and after two weeks. Also TSH will be determined after two weeks as in standard care. The thyroid specimen will be send to pathology. In the specimen, the pathologist will search for parathyroid glands, as is standard care. Furthermore, video recordings will be analyzed, quantifying the fluorescence signal compared to the background: measuring the Target to Background Ratio. Also, in these video recordings the time until visualization of the parathyroid glands will be reassessed by an independent expert.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRF imaging in thyroid surgery | Experimental | Device: NIRF imaging in thyroid surgery7.5 mg ICG is administered i.v. and the system will be switched to fluorescence mode. If needed, a second dose of 7.5 mg ICG can be administered. After identification of the parathyroid glands, surgery will continue until there is a desire to visualize the parathyroid glands again, another dose of ICG can be given. After complete removal of thyroid, another 7.5 mg of ICG will be given to assess the perfusion of the parathyroid gland. Directly after the procedure the researcher will ask the surgeon whether he/she thinks the technique is feasible. After surgery, the serum calcium levels will be determined in patients after total thyroidectomy on day 1, 2 and after two weeks. TSH will be determined after 2 weeks. The thyroid specimen will be send to pathology. In the specimen, the pathologist will search for parathyroid glands. Video recordings will be analyzed, quantifying the fluorescence signal compared to the background: measuring the TBR. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female patients, aged 18 years and above
- Scheduled for elective total or hemi thyroidectomy
- Normal liver and renal function
- No known hypersensitivity for iodine or ICG
- Able to understand the nature of the study procedures
Key exclusion criteria (7 listed)
- Age < 18 years
- Liver or renal insufficiency
- Known ICG, iodine, penicillin or sulfa hypersensitivity
- Pregnancy or breastfeeding
- Not able to understand the nature of the study procedure
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 |
|---|---|---|
| NIRF imaging in thyroid surgeryAlso: Near Infrared Fluorescence Imaging, Indocyanine greena fluorescence imaging system and 7.5 mg of ICG will be used to visualize the parathyroids glands. | Device | NIRF imaging in thyroid surgery |
Primary outcome
Time to identification of parathyroid glans
Time frame: during surgery
Can the parathyroid glands be identified earlier with NIRF light? Time until identification in NIRF and white light will be compared.
4 secondary outcomes
Total surgical time
Time frame: From incision until closure
Histology: are parathyroid glands in the specimen? (as in standard care)
Time frame: assessment within 1 week after surgery
Subjective opinion surgeon about the usefulness of the technique
Time frame: Immediately after surgery
Intra-operative complications due to the use of the technique
Time frame: during surgery
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 14 Mar 2018.
- Individual participant dataSharing planned: No
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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.
Nicole Bouvy, M.D. Ph.D. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NIRF imaging in thyroid surgery in people with Thyroid Disease, run by Maastricht University Medical Center at 1 site 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 6 inclusion and 7 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 14 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Time to identification of parathyroid glans (time frame: during surgery). 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 14 Mar 2018.