Overview
Sponsor-declared trial summary
Thyroid Diseases Hypoparathyroidism Hypocalcemia
Compare the incidence of albumin-corrected hypocalcaemia (blood calcium less than 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the group using indocyanine green and the group not using indocyanine green.
Key facts
- Sponsor
- Centre Hospitalier Regional Et Universitaire De Brest
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hormonal diseases [C19]
- Decision date (initial)
- 2024-07-31
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-516255-41-00
- EudraCT number
- 2020-005189-32
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Prophylaxis
Compare the incidence of albumin-corrected hypocalcaemia (blood calcium less than 2 mmol/L, a sign associated with hypoparathyroidism) postoperatively between the group using indocyanine green and the group not using indocyanine green.
Secondary objectives 6
- To assess the contribution of indocyanine green angiography in modifying the rate of definitive hypoparathyroidism after total thyroidectomy (D8, M1, M6).
- To determine the contribution of indocyanine green angiography (ICG) during total thyroidectomy for in vivo location and preservation of the parathyroids.
- Assessing the contribution of indocyanine green angiography in predicting postoperative hypocalcaemia
- To determine the value of indocyanine green angiography (ICG) in predicting hypoparathyroidism after total thyroidectomy.
- Compare the frequency of postoperative hypocalcaemia, according to its grade (mild, moderate and profound), between the group using indocyanine green and the group not using indocyanine green.
- To assess the tolerance of indocyanine green
Conditions and MedDRA coding
Thyroid Diseases Hypoparathyroidism Hypocalcemia
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Patients requiring total thyroidectomy
- Signed consent
- Patient covered by a social security scheme
Exclusion criteria 8
- Patients under 18 years of age
- Protected adult or person incapable of giving consent to the study
- Pregnant and breast-feeding women
- Total thyroidectomy (removal of the remaining thyroid lobe in a patient who has already had a hemi thyroidectomy)
- Previous thyroid or parathyroid surgery
- Refusal to participate
- Known allergic reaction to indocyanine green (ICG)
- Women of childbearing age not using an adequate method of contraception
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Occurrence (yes/no) of albumin-corrected hypocalcaemia (≤2 mmol/L) within 48 hours of surgery
Secondary endpoints 6
- Occurrence (yes/no) of post-operative hypocalcaemia corrected by albumin (<2mmol/L) at D8, M1 and M6
- Modification (yes/no) of the surgical procedure by improving detection of the parathyroids or their vascularisation during thyroidectomy with the use of indocyanine green angiography
- Intraoperative parathyroid vitality score when using indocyanine green angiography
- Occurrence (yes/no) of hypoPTH on D1 and D2 post-op (<10ng/L)
- Occurrence (yes/no) of mild (asymptomatic and >1.7mmol/l), moderate (symptomatic and >1.7mmol/l) and profound (<1.7mmol/l) hypocalcaemia in the 48 postoperative hours
- Occurrence of an adverse reaction linked to the injection of indocyanine green
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
INFRACYANINE 25 mg/10 mL, poudre et solvant pour solution injectable
PRD345900 · Product
- Active substance
- Indocyanine Green
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 0.5 mg/Kg milligram(s)/kilogram
- Max total dose
- 0.5 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V04CX — OTHER DIAGNOSTIC AGENTS
- Marketing authorisation
- 34009 360 841 7 9
- MA holder
- SERB
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional Et Universitaire De Brest
- Sponsor organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Address
- 2 Avenue Marechal Foch
- City
- Brest
- Postcode
- 29200
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Dr Jean-Christophe LECLERE
Public contact point
- Organisation
- Centre Hospitalier Regional Et Universitaire De Brest
- Contact name
- Dr Jean-Christophe LECLERE
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Authorised, recruitment pending | 242 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2020-005189-32 | 3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 1.1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC INFRACYANINE | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis FR 2020-005189-32 | 3 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-07-08 | France | Acceptable 2024-07-30
|
2024-07-31 |