Thyroid DiseasesPhase 3HYPOCAAVINCT04785443
Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
A Phase 3 study testing ICG in people with Thyroid Diseases, run by University Hospital, Brest at 1 site in France.
Trial summary
Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It becomes permanent after 6 months. Untreated permanent hypoparathyroidism is a source of numerous complications in general and therefore requires lifelong replacement therapy resulting in a significant deterioration in quality of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thyroid Diseases
- What is being tested?
- ICG
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jun 2021to 22 Jun 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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
- Patient having to undergo a total thyroidectomy
- Signed consent
- Patient beneficiary of a social security regimen
Who cannot join
- Minor patient under 18 years old
- Major patient protected by law or unable to give informed consent
- Pregnant or breastfeeding woman
- Thyroidectomy totalization
- History of thyroid or parathyroid surgery
- Participation refusal
- Known allergy to ICG
- Woman of child-bearing age not using adequate method of contraception
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29609
Jean-Christophe LECLERE
Gael POTARD
About this study
Official title: Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
- Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It becomes permanent after 6 months.
- Untreated permanent hypoparathyroidism is a source of numerous complications in general and therefore requires lifelong replacement therapy resulting in a significant deterioration in quality of life.
- The intraoperative use of indocyanine green (ICG) angiography has recently been described as a reliable means of detecting parathyroidism and predicting the risk of postoperative hypoparathyroidism.
- This use could prove to be a way to preserve parathyroid in vivo and thus reduce post-operative hypoparathyroidism rates.
Read the detailed description
Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It is most often transient but can sometimes be permanent when it persists for more than 6 months after surgery. The rates are variable, of the order of 32% for transient hypoparathyroidism and 1% for definitive hypoparathyroidism. Untreated permanent hypoparathyroidism is the source of many complications in general and therefore requires lifelong replacement therapy. The result is a significant deterioration in quality of life.
The mechanisms responsible for hypoparathyroidism during thyroidectomy are direct damage to the parathyroid glands, involuntary excision of these glands, and devascularization of these glands.
The detection of parathyroid glands and the prevention of hypoparathyroidism after thyroidectomy therefore represents a major challenge.
The intraoperative use of indocyanine green angiography has recently been described as a reliable means of detecting parathyroid and predicting the risk of postoperative hypoparathyroidism.
In addition, prior studies and intraoperative observations suggest that indocyanine green angiography during thyroid surgery may be a means of preserving parathyroid in vivo and thus reducing post-operative hypoparathyroidism rates.
- Conditions
- Thyroid Diseases
- Being tested
- ICG, Control group
- Keywords
- Hypocalcemia, Hypoparathyroidism, Angiography
- Medical subject headings
- Thyroid Diseases, Hypocalcemia, Hypoparathyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICGDrug
During thyroidectomy surgery, the patient will received 2 or 3 injections of 5 mg as a bolus. The first one during the dissection of the first lobe, then during the dissection of the second lobe and finally if needed, a 3rd injection will be done at the end of the dissection.
Patients will then be followed during 6 months.
Control groupProcedure or surgery
During thyroidectomy surgery, patients are treated according to traditional surgery with detection of parathyroids with the naked eyes.
Patients will then be followed during 6 months.
| Study group | Role | What they receive |
|---|---|---|
| ICG group | Experimental | Patient receiving 2 or 3 intraoperative injections of indocyanine green. Receives: Drug: ICG |
| Control group | Other | Patient benefiting from the traditional surgical act Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the frequency of albumin-corrected hypocalcemia (blood sugar below 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the ICG group and the control group.
Frequency of albumin-corrected hypocalcemia (≤2 mmol/L) within 48 hours postoperatively.
Measured: Day 2
Secondary outcomes (6)
Evaluate the contribution of ICG angiography in the modification of the rate of definitive hypoparathyroidism after total thyroidectomy.
Occurrence (yes/no) of albumin-corrected (<2mmol/L) postoperative hypocalcemia at D8, M1 and M6
Measured: Day 8, Month 1 and Month 6
Determine the contribution of indocyanine green angiography (ICG) during the total thyroidectomy procedure for in vivo detection and preservation of parathyroid glands.
Modification (yes/no) of the surgical procedure by improving the detection of parathyroids or their vascularization during thyroidectomy with the use of indocyanine green angiography.
Measured: Day 0
To evaluate the contribution of indocyanine green angiography in the prediction of postoperative hypocalcemia.
Intraoperative parathyroid vitality score (0=devascularized parathyroid gland to 2 = vascularized thyroid gland) when using indocyanine green angiography.
Measured: Day 0
To determine the interest of indocyanine green angiography (ICG) in the prediction of hypoparathyroidism after total thyroidectomy.
Occurrence (yes/no) of hypo parathormone at D1 and D2 postoperatively (<10ng/L).
Measured: Day 1 and Day 2
Compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate and deep), between the ICG group and the control group.
Frequency of mild (asymptomatic and >1.7mmol/l), moderate (symptomatic and >1.7mmol/l) and profound (<1.7mmol/l) hypocalcemia within 48 hours postoperatively.
Measured: D1 and D2
Evaluate the tolerance of indocyanine green.
Occurrence of an adverse event related to the injection of indocyanine green.
Measured: Day 1, Day 2, Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start22 Jun 2021
- Primary completion22 Jun 2026 (estimated)
- Study completion22 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric, comparative, randomized, single-blind, controlled trial against the reference method
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Christophe LECLERE, PhD, Principal investigator, CHRU de Brest
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04785443
- Sponsor's protocol ID
- 29BRC20.0208
- Acronym
- HYPOCAAVI
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2021
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contribution of Indocyanine Green Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy
- ClinicalTrials.gov ID
- NCT04785443
- Acronym / sponsor ID
- HYPOCAAVI / 29BRC20.0208
- Conditions
- Thyroid Diseases
- Keywords
- Hypocalcemia, Hypoparathyroidism, Angiography
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 22 Jun 2026 (estimated)
- Study completion
- 22 Jun 2027 (estimated)
- First posted
- 5 Mar 2021 (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.
- Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It becomes permanent after 6 months.
- Untreated permanent hypoparathyroidism is a source of numerous complications in general and therefore requires lifelong replacement therapy resulting in a significant deterioration in quality of life.
- The intraoperative use of indocyanine green (ICG) angiography has recently been described as a reliable means of detecting parathyroidism and predicting the risk of postoperative hypoparathyroidism.
- This use could prove to be a way to preserve parathyroid in vivo and thus reduce post-operative hypoparathyroidism rates.
Detailed description
Hypoparathyroidism is the most common complication after a total thyroidectomy surgery. It is most often transient but can sometimes be permanent when it persists for more than 6 months after surgery. The rates are variable, of the order of 32% for transient hypoparathyroidism and 1% for definitive hypoparathyroidism. Untreated permanent hypoparathyroidism is the source of many complications in general and therefore requires lifelong replacement therapy. The result is a significant deterioration in quality of life.
The mechanisms responsible for hypoparathyroidism during thyroidectomy are direct damage to the parathyroid glands, involuntary excision of these glands, and devascularization of these glands.
The detection of parathyroid glands and the prevention of hypoparathyroidism after thyroidectomy therefore represents a major challenge.
The intraoperative use of indocyanine green angiography has recently been described as a reliable means of detecting parathyroid and predicting the risk of postoperative hypoparathyroidism.
In addition, prior studies and intraoperative observations suggest that indocyanine green angiography during thyroid surgery may be a means of preserving parathyroid in vivo and thus reducing post-operative hypoparathyroidism rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Monocentric, comparative, randomized, single-blind, controlled trial against the reference method
| Arm | Type | Receives |
|---|---|---|
| ICG group | Experimental | Drug: ICGPatient receiving 2 or 3 intraoperative injections of indocyanine green. |
| Control group | Other | Procedure: Control groupPatient benefiting from the traditional surgical act |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient having to undergo a total thyroidectomy
- Signed consent
- Patient beneficiary of a social security regimen
Key exclusion criteria (8 listed)
- Minor patient under 18 years old
- Major patient protected by law or unable to give informed consent
- Pregnant or breastfeeding woman
- Thyroidectomy totalization
- History of thyroid or parathyroid 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 |
|---|---|---|
| ICGDuring thyroidectomy surgery, the patient will received 2 or 3 injections of 5 mg as a bolus. The first one during the dissection of the first lobe, then during the dissection of the second lobe and finally if needed, a 3rd injection will be done at the end of the dissection. Patients will then be followed during 6 months. | Drug | ICG group |
| Control groupDuring thyroidectomy surgery, patients are treated according to traditional surgery with detection of parathyroids with the naked eyes. Patients will then be followed during 6 months. | Procedure or surgery | Control group |
Primary outcome
Compare the frequency of albumin-corrected hypocalcemia (blood sugar below 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the ICG group and the control group.
Time frame: Day 2
Frequency of albumin-corrected hypocalcemia (≤2 mmol/L) within 48 hours postoperatively.
6 secondary outcomes
Evaluate the contribution of ICG angiography in the modification of the rate of definitive hypoparathyroidism after total thyroidectomy.
Time frame: Day 8, Month 1 and Month 6
Determine the contribution of indocyanine green angiography (ICG) during the total thyroidectomy procedure for in vivo detection and preservation of parathyroid glands.
Time frame: Day 0
To evaluate the contribution of indocyanine green angiography in the prediction of postoperative hypocalcemia.
Time frame: Day 0
To determine the interest of indocyanine green angiography (ICG) in the prediction of hypoparathyroidism after total thyroidectomy.
Time frame: Day 1 and Day 2
Compare the frequency of postoperative hypocalcemia, according to its grade (mild, moderate and deep), between the ICG group and the control group.
Time frame: D1 and D2
Evaluate the tolerance of indocyanine green.
Time frame: Day 1, Day 2, Day 10
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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.
Jean-Christophe LECLERE, PhD principal investigator
CHRU de Brest
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ICG in people with Thyroid Diseases, run by University Hospital, Brest at 1 site in France.
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 3 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 19 Mar 2026. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Christophe LECLERE, PhD (0298223630 ext. +33, jean-christophe.leclere@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the frequency of albumin-corrected hypocalcemia (blood sugar below 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the ICG group and the control group. (time frame: Day 2). 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 19 Mar 2026.