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NCT03012438

NIRF for Parathyroid Visualization: a Pilot Study

Completed NA Last updated 14 March 2018
What this trial tests

NA trial testing NIRF imaging in thyroid surgery in Thyroid Disease in 30 participants. Completed in 12 March 2018.

Timeline
23 March 2017
Primary endpoint
1 February 2018
12 March 2018

Quick facts

Lead sponsorMaastricht University Medical Center
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment30
Start date23 March 2017
Primary completion1 February 2018
Estimated completion12 March 2018
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Maastricht University Medical Center

Who can join

18 and older, any sex, with Thyroid Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Feasibility of indocyanine green fluorescence imaging for intraoperative identification of parathyroid glands during thyroid surgery.
    van den Bos J, van Kooten L, Engelen SME, Lubbers T, et al · · 2019 · cited 41× · PMID 30536963 · DOI 10.1002/hed.25451

Verify or expand the search:

Other recruiting trials for Thyroid Disease

Currently open trials in the same condition.

Other Maastricht University Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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