Thyroid CancerNCT04424485
Near-infrared Fluorescence With Indocyanine Green for Identification of Sentinels and Parathyroids During Thyroidectomy
A study testing Total thyroidectomy (TT), Central lymph node dissection (CLND) and Sentinel lymph node (SLN) bopsy in people with Thyroid Cancer and Thyroid Carcinoma, Papillary, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications. Read more about this study
- Who is it for?
- Ages 17 to 80 years
- Conditions the study is for
- Thyroid Cancer, Thyroid Carcinoma, Papillary, Thyroid Metastases
- What is being tested?
- Total thyroidectomy (TT), Central lymph node dissection (CLND) and Sentinel lymph node (SLN) bopsy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2020to 1 Jun 2021
- 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 17 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure
- Patients at or over 17 years
Who cannot join
- Previous thyroid surgery
- Patients below 17 years
Trial locations and contacts
1 site in 1 country.
Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof. contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Umraniye Education and Research Hospital, Department of General Surgery
Istanbul, 34760
Ethem Unal, MD, PhD, A. Prof. of Surgery & Surgical Oncology, +90 216 632 1818 ext. 1950, drethemunal@gmail.com
Sema Yuksekdag, MD, +90 216 632 1818 ext. 1950, drsemayuksekdag@gmail.com
About this study
Official title: Near-infrared (NIR) Fluorescence Imaging With Indocyanine Green (ICG) for Identification of Sentinel Lymph Nodes and Parathyroid Glands During Total Thyroidectomy: Prospective Randomized Clinical Trial
Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) imaging has been recently introduced, and has been suggested as a useful tool for the identification and preservation of the parathyroid glands (PGs) during total thyroidectomy (TT). ICG can also be used for sentinel lymph node (SLN) biopsy to predict the micrometastases in central lymph nodes (CLN) in thyroid carcinoma, and central lymph node dissection can reduce local recurrence.
Read the detailed description
Incidence of thyroid cancer has doubled between 1980 and 2020, and it is now the fifth most common malignant tumor among women. The majority are papillary thyroid cancer (PTC), and TT is the procedure of choice. Since the micrometastasis rate of the central lymph nodes (CLNs) is about 30% to 90% in PTC, CLN dissection can improve the prognosis and reduce tumor recurrence as well as provide accurate information for the evaluation of tumor staging. However, TT procedure has some important complications such as vocal cord paralysis (VCP) and hypocalcemia (due to accicental parathyroidectomy or damage to the parathyroid gland-PG- vasculature). Use of intraoperative nerve monitoring (IONM) has reduced the rate of VCP. However, the incidence of postoperative hypocalcemia is still high (15-70%), and it is now the most common complication of TT. Intraoperative identification of SLNs and PGs can help surgeon to overcome these problems.
- Conditions
- Thyroid Cancer, Thyroid Carcinoma, Papillary, Thyroid Metastases, Thyroid Neoplasms, Sentinel Lymph Node, Lymph Node Metastases
- Being tested
- Total thyroidectomy (TT), Central lymph node dissection (CLND), Sentinel lymph node (SLN) bopsy, Identification of parathyroid glands (PGs)
- Keywords
- Near-infrared (NIR) fluorescence, Total thyroidectomy, Parathyroid glands, Indocyanine green (ICG), Central lymph node dissection
- Medical subject headings
- Thyroid Neoplasms, Thyroid Cancer, Papillary, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total thyroidectomy (TT)Procedure or surgery
Standard TT procedure for thyroid carcinoma, for both groups
Central lymph node dissection (CLND)Procedure or surgery
Standard CLND for thyroid carcinoma, for both groups
Sentinel lymph node (SLN) bopsyDiagnostic test
Intrathyroidal injection of ICG for SL biopsy, for only experimental group
Identification of parathyroid glands (PGs)Diagnostic test
Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
| Study group | Role | What they receive |
|---|---|---|
| Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy | Active comparator | Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC)
Standard TT+CLND procedure only Receives: Procedure: Total thyroidectomy (TT); Procedure: Central lymph node dissection (CLND) |
| Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node | Experimental | Experimental group- Sentinel lymph node dissection (SLND) after intratumoral indocyanine green (ICG) injection and visualization of all 4 parathyroid glands with infra-red (NIR) fluorescence after intravenous (iv) ICG injection, during total thyroidectomy and central lymph node dissection (CLND).
TT+CLND with NIR fluorescence ICG Receives: Procedure: Total thyroidectomy (TT); Procedure: Central lymph node dissection (CLND); Diagnostic Test: Sentinel lymph node (SLN) bopsy; Diagnostic Test: Identification of parathyroid glands (PGs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion
Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy
Measured: 1 year
Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast
İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)
Measured: 1 year
Secondary outcomes (1)
Central lymph node dissetion (CLND)
Number of positive lymph nodes (micrometastases)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Thyroid CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Umraniye Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ethem Unal, M.D., PhD, Associate Prof of Surgery & Surgic, Umraniye Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04424485
- Sponsor's protocol ID
- B.10.1.TKH.4.34.H.GP.0.01/213
- Status last verified
- Jun 2020
- First submitted
- 2 Jun 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Excel data is available upon request at drethemunal@gmail.com
Publications
Zhang X, Shen YP, Li JG, Chen G. Clinical feasibility of imaging with indocyanine green combined with carbon nanoparticles for sentinel lymph node identification in papillary thyroid microcarcinoma. Medicine (Baltimore). 2019 Sep;98(36):e16935. doi: 10.1097/MD.0000000000016935.
PubMed 31490376Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741.
PubMed 31882459
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near-infrared (NIR) Fluorescence Imaging With Indocyanine Green (ICG) for Identification of Sentinel Lymph Nodes and Parathyroid Glands During Total Thyroidectomy: Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04424485
- Acronym / sponsor ID
- B.10.1.TKH.4.34.H.GP.0.01/213
- Conditions
- Thyroid Cancer, Thyroid Carcinoma, Papillary, Thyroid Metastases, Thyroid Neoplasms, Sentinel Lymph Node, Lymph Node Metastases
- Keywords
- Near-infrared (NIR) fluorescence, Total thyroidectomy, Parathyroid glands, Indocyanine green (ICG), Central lymph node dissection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Umraniye Education and Research HospitalOther government
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 11 Jun 2020 (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.
Indocyanine green (ICG) is a water-soluble organic dye that is cleared totally through the hepatobiliary system. It has a half-life of 3-4 mins, which allows repeated applications. Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) imaging has been recently introduced, and has been suggested as a useful tool for the identification and preservation of the parathyroid glands (PGs) during total thyroidectomy (TT). ICG can also be used for sentinel lymph node (SLN) biopsy to predict the micrometastases in central lymph nodes (CLN) in thyroid carcinoma, and central lymph node dissection can reduce local recurrence.
Detailed description
Incidence of thyroid cancer has doubled between 1980 and 2020, and it is now the fifth most common malignant tumor among women. The majority are papillary thyroid cancer (PTC), and TT is the procedure of choice. Since the micrometastasis rate of the central lymph nodes (CLNs) is about 30% to 90% in PTC, CLN dissection can improve the prognosis and reduce tumor recurrence as well as provide accurate information for the evaluation of tumor staging. However, TT procedure has some important complications such as vocal cord paralysis (VCP) and hypocalcemia (due to accicental parathyroidectomy or damage to the parathyroid gland-PG- vasculature). Use of intraoperative nerve monitoring (IONM) has reduced the rate of VCP. However, the incidence of postoperative hypocalcemia is still high (15-70%), and it is now the most common complication of TT. Intraoperative identification of SLNs and PGs can help surgeon to overcome these problems.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy | Active comparator | Procedure: Total thyroidectomy (TT), Procedure: Central lymph node dissection (CLND)Control group-Total thyroidectomy (TT) with central lymph node dissection (CLND) procedure for patients with papillary thyroid carcinoma (PTC) Standard TT+CLND procedure only |
| Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node | Experimental | Procedure: Total thyroidectomy (TT), Procedure: Central lymph node dissection (CLND), Diagnostic Test: Sentinel lymph node (SLN) bopsy, Diagnostic Test: Identification of parathyroid glands (PGs)Experimental group- Sentinel lymph node dissection (SLND) after intratumoral indocyanine green (ICG) injection and visualization of all 4 parathyroid glands with infra-red (NIR) fluorescence after intravenous (iv) ICG injection, during total thyroidectomy and central lymph node dissection (CLND). TT+CLND with NIR fluorescence ICG |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Thyroid carcinoma patients (biopsy/cytology-proven) suitable for total thyroidectomy procedure
- Patients at or over 17 years
Key exclusion criteria (2 listed)
- Previous thyroid surgery
- Patients below 17 years
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 |
|---|---|---|
| Total thyroidectomy (TT)Standard TT procedure for thyroid carcinoma, for both groups | Procedure or surgery | Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node, Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy |
| Central lymph node dissection (CLND)Standard CLND for thyroid carcinoma, for both groups | Procedure or surgery | Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node, Thyroid carcinoma patients (biopsy-proven)-Total thyroidectomy |
| Sentinel lymph node (SLN) bopsyIntrathyroidal injection of ICG for SL biopsy, for only experimental group | Diagnostic test | Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node |
| Identification of parathyroid glands (PGs)Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group | Diagnostic test | Thyroid carcinoma patients (biopsy-proven)-Sentinel lymph node |
Primary outcome
Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion
Time frame: 1 year
Intrathyroidal injection of indocyanine green (ICG) dye to identify sentinel lymph node (SLN) for biopsy
Identification of parathyroid glands (PGs) by NIR/ICG camera detected high-contrast
Time frame: 1 year
İntravenous injection of ICG dye, to identify PGs under NIR (High-contrast fluorescence seen or not)
1 secondary outcome
Central lymph node dissetion (CLND)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Results publication: PubMed 31490376Zhang X, Shen YP, Li JG, Chen G. Clinical feasibility of imaging with indocyanine green combined with carbon nanoparticles for sentinel lymph node identification in papillary thyroid microcarcinoma. Medicine (Baltimore). 2019 Sep;98(36):e16935. doi: 10.1097/MD.0000000000016935.
- Results publication: PubMed 31882459Spartalis E, Ntokos G, Georgiou K, Zografos G, Tsourouflis G, Dimitroulis D, Nikiteas NI. Intraoperative Indocyanine Green (ICG) Angiography for the Identification of the Parathyroid Glands: Current Evidence and Future Perspectives. In Vivo. 2020 Jan-Feb;34(1):23-32. doi: 10.21873/invivo.11741.
- Ethem UnalLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Excel data is available upon request at drethemunal@gmail.com
Related trials for Thyroid Cancer
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
RecruitingObservational study
DICER1-related Pleuropulmonary Blastoma Cancer Predisposition Syndrome: A Natural History Study
Pleuropulmonary Blastoma, Cystic Nephroma
Recruiting
Evaluation of DNA Methylation Signatures for the Diagnosis and Management of Thyroid Nodules
Thyroid Gland Carcinoma
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.
Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Total thyroidectomy (TT), Central lymph node dissection (CLND) and Sentinel lymph node (SLN) bopsy in people with Thyroid Cancer and Thyroid Carcinoma, Papillary, run by Umraniye Education and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ethem Unal, MD, PhD, USMLE&IFSO-CSS, A. Prof. (+90 216 632 1818 ext. 1950, drethemunal@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Involvement of sentinel lymph node (presence/absence of tumor cell: positive or negative) by histopathological examinatiion (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04424485, which also lists 2 linked publications.
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 11 Jun 2020.