Thyroid Disease Clinical Trial
Official title:
The Use of Near-Infrared Fluorescence Imaging in Parathyroid Visualization During Thyroid Surgery: a Pilot Study
Verified date | April 2017 |
Source | Maastricht University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | March 12, 2018 |
Est. primary completion date | February 1, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Netherlands | Maastricht University Medical Center | Maastricht | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Quantitative measurement of fluorescence signal related to parathyroid function | Quantitative measurement of fluorescence signal using Target to Background Ratio (TBR) is used, combined with parameters of parathyroid function, namely Calcium levels postoperatively day 1 and day 2, and week 2 in patients after total thyroidectomy (as in standard care), and TSH in patients after total thyroidectomy 2 weeks postoperatively (as in standard care). | up to 2 weeks | |
Primary | 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. | during surgery | |
Secondary | Total surgical time | From incision until closure | ||
Secondary | 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. | assessment within 1 week after surgery | |
Secondary | Subjective opinion surgeon about the usefulness of the technique | Immediately after surgery | ||
Secondary | Intra-operative complications due to the use of the technique | during surgery |
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