Thyroid CancerPhase 4NCT03969108
Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
A Phase 4 study testing Indocyanine Green in people with Thyroid Cancer and Thyroid Goiter, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Cancer, Thyroid Goiter, Graves Disease
- What is being tested?
- Indocyanine Green
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 6 Aug 2019to 13 Nov 2019
- Phase
- Phase 4
- 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
- Patients ≥ 18 years
- Patients undergoing total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter
- Patients are eligible for surgery
- Patients are mentally competent and are able and willing to comply with study procedures
- Written informed consent
Who cannot join
- Patients with a known allergy to ICG or iodinated contrast
- Pregnant or lactating women
- Patients with previous neck surgery
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.
Read the detailed description
Background Thyroid surgery volume continues to increase worldwide over the past few decades. During a total thyroidectomy (TTx), the ultimate goal is to remove all thyroid tissue, whereas damage to adjacent tissue is prevented. However, iatrogenic hypoparathyroidism, as a result of surgical removal or damage to the parathyroid glands, occurs in approximately 30% of the cases. In 2016 near-infrared fluorescence guided surgery with indocyanine green (ICG) was proposed for visualizing viability and blood supply of parathyroid glands during TTx. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins once in the bloodstream, and circulates in the intravascular compartment only. However, one of the limitations of ICG imaging is the subjectivity of the interpretation of fluorescence, which makes the assessment of images inconsistent among studies. There is a clear need for standardization of the evaluation of the perfusion with ICG, since visual evaluation of the fluorescent signal of ICG is not sufficient to reliably predict the perfusion of parathyroid glands.
Main research question To develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy including quantitative evaluations of the fluorescent signal.
Design This will be a proof-of-concept , prospective cohort study of patients undergoing a total thyroidectomy with ICG-guided fluorescent surgery to evaluate tissue perfusion The main study endpoint is quantification of the fluorescent signal of ICG. Secondary outcomes are data from surgery, postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.
- Conditions
- Thyroid Cancer, Thyroid Goiter, Graves Disease
- Being tested
- Indocyanine Green
- Keywords
- Thyroid surgery, Indocyanine green (ICG), Hypoparathyroidism
- Medical subject headings
- Thyroid Neoplasms, Goiter, Graves Disease, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine GreenDrug
ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.
| Study group | Role | What they receive |
|---|---|---|
| Indocyanine Green | Experimental | Not described Receives: Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of the fluorescent signal of ICG
Quantification of the fluorescent signal of ICG
Measured: At time of surgery
Secondary outcomes (6)
Appearance of parathyroid gland
Vascularization appearance of parathyroid gland intraoperatively (1= surgeon thinks parathyroid gland is well vascularized, 2 = surgeons thinks parathyroid gland is devascularized)
Measured: At time of surgery
Duration of surgery
Duration of surgery in minutes
Measured: From start to end of surgery
Postoperative calcium concentration
Postoperative albumin-corrected calcium concentration in blood
Measured: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Postoperative PTH concentration
Postoperative PTH concentration in blood
Measured: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Rate of prescribed postoperative calcium medication
Rate of prescribed postoperative calcium medication
Measured: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Rate of prescribed postoperative vitamin D medication
Rate of prescribed postoperative vitamin D medication
Measured: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2019
- Study start6 Aug 2019
- Primary completion12 Nov 2019
- Study completion13 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jesse Pasternak, MD, MPHc, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03969108
- Sponsor's protocol ID
- 19-5447
- Status last verified
- Mar 2020
- First submitted
- 24 May 2019
- Last updated
- 27 Mar 2020
- Results posted
- No
- 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 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
- ClinicalTrials.gov ID
- NCT03969108
- Acronym / sponsor ID
- 19-5447
- Conditions
- Thyroid Cancer, Thyroid Goiter, Graves Disease
- Keywords
- Thyroid surgery, Indocyanine green (ICG), Hypoparathyroidism
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 6 Aug 2019 (actual)
- Primary completion
- 12 Nov 2019 (actual)
- Study completion
- 13 Nov 2019 (actual)
- First posted
- 31 May 2019 (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.
This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.
Detailed description
Background Thyroid surgery volume continues to increase worldwide over the past few decades. During a total thyroidectomy (TTx), the ultimate goal is to remove all thyroid tissue, whereas damage to adjacent tissue is prevented. However, iatrogenic hypoparathyroidism, as a result of surgical removal or damage to the parathyroid glands, occurs in approximately 30% of the cases. In 2016 near-infrared fluorescence guided surgery with indocyanine green (ICG) was proposed for visualizing viability and blood supply of parathyroid glands during TTx. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins once in the bloodstream, and circulates in the intravascular compartment only. However, one of the limitations of ICG imaging is the subjectivity of the interpretation of fluorescence, which makes the assessment of images inconsistent among studies. There is a clear need for standardization of the evaluation of the perfusion with ICG, since visual evaluation of the fluorescent signal of ICG is not sufficient to reliably predict the perfusion of parathyroid glands.
Main research question To develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy including quantitative evaluations of the fluorescent signal.
Design This will be a proof-of-concept , prospective cohort study of patients undergoing a total thyroidectomy with ICG-guided fluorescent surgery to evaluate tissue perfusion The main study endpoint is quantification of the fluorescent signal of ICG. Secondary outcomes are data from surgery, postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indocyanine Green | Experimental | Drug: Indocyanine Green |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients ≥ 18 years
- Patients undergoing total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter
- Patients are eligible for surgery
- Patients are mentally competent and are able and willing to comply with study procedures
- Written informed consent
Key exclusion criteria (3 listed)
- Patients with a known allergy to ICG or iodinated contrast
- Pregnant or lactating women
- Patients with previous neck surgery
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 |
|---|---|---|
| Indocyanine GreenICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system. | Drug | Indocyanine Green |
Primary outcome
Quantification of the fluorescent signal of ICG
Time frame: At time of surgery
Quantification of the fluorescent signal of ICG
6 secondary outcomes
Appearance of parathyroid gland
Time frame: At time of surgery
Duration of surgery
Time frame: From start to end of surgery
Postoperative calcium concentration
Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Postoperative PTH concentration
Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Rate of prescribed postoperative calcium medication
Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Rate of prescribed postoperative vitamin D medication
Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
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 27 Mar 2020.
- Individual participant dataSharing planned: No
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.
Jesse Pasternak, MD, MPHc principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Indocyanine Green in people with Thyroid Cancer and Thyroid Goiter, run by University Health Network, Toronto at 1 site in Canada.
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 5 inclusion and 3 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 27 Mar 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 Canada. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Quantification of the fluorescent signal of ICG (time frame: At time of 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 27 Mar 2020.