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NCT03012438
NIRF for Parathyroid Visualization: a Pilot Study
NA trial testing NIRF imaging in thyroid surgery in Thyroid Disease in 30 participants. Completed in 12 March 2018.
1 February 2018
Quick facts
| Lead sponsor | Maastricht University Medical Center |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 30 |
| Start date | 23 March 2017 |
| Primary completion | 1 February 2018 |
| Estimated completion | 12 March 2018 |
| Sites | 1 location across Netherlands |
Drugs / interventions tested
- NIRF imaging in thyroid surgery
Conditions studied
- Thyroid Disease — all drugs for Thyroid Disease →
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):
-
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:
- PubMed search for NCT03012438
- Europe PMC full search
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Related trials
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Other Maastricht University Medical Center trials
Trials by the same sponsor.
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- NCT04598516 — Maastricht Investigation of Renal Function in Absence of- and Post- Contrast in Patients With eGFR LEss Than 30 · withdrawn
- NCT04597892 — Efficacy of Point-Of-Care Creatinine Assays in Patients With eGFR <30 Receiving Intravascular Contrast · withdrawn
- NCT07287358 — Optimal Cerebral Perfusion Pressure Guided Therapy: Assessment of Target Effectiveness - II · NA · not yet recruiting
- NCT07501780 — Real-world Evaluation of the Implementation of LC-OCT in Daily Clinical Practice · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03012438 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maastricht University Medical Center
- Last refreshed: 14 March 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03012438.
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