Clinical trial · Interventional
Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation
NCT06169735CI-TRIAL-00110681terminatedPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding halted
Summary
Brief summary (as posted)
The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenoma | Adenoma | ONTOLOGY_EXACT | 0.98 |
| Parathyroid Dysfunction | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
| SPY Portable Handheld Imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Parathyroid patients
- description
- patients who require parathyroid identification and preservation during parathyroid surgery maneuver
- interventionNames
- Drug: Indocyanine green
- Device: SPY Portable Handheld Imaging
Primary outcomes (1)
- measure
- Percentage of Parathyroid Glands identified by ICG
- timeFrame
- 20 minutes
- description
- Measuring the percentage of the number of glands per participant that emit fluorescence. ICG Administration: All enrolled patients with scheduled thyroidectomy or parathyroidectomy will receive a standard cervical incision that afford access to either side of neck. Following sufficient exposure of thyroid, 25 mg of indocyanine green (ICG), reconstituted in 10 ml of sterile water, will be administered intravenously. A dosage of 1 ml of this solution will be injected into a peripheral IV line, followed by a 5 ml flush of normal saline to ensure the propagation of the dye within the vascular compartment. Fluorescent Imaging: Approximately 30 seconds post-administration, the parathyroid glands are expected to exhibit fluorescence under near-infrared imaging. The emitted fluorescence is anticipated to persist for approximately 20 minutes, allowing ample time for intraoperative evaluation of parathyroid viability and perfusion.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * age greater than 18 years old Exclusion Criteria: * Patients with iodine or shellfish allergies would be excluded. * Patients with allergy to indocyanine green. * Pregnancy
References
Publications (8)
- BACKGROUNDEdafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9. PMID 24402815
- BACKGROUNDCarter Y, Chen H, Sippel RS. An intact parathyroid hormone-based protocol for the prevention and treatment of symptomatic hypocalcemia after thyroidectomy. J Surg Res. 2014 Jan;186(1):23-8. doi: 10.1016/j.jss.2013.09.026. Epub 2013 Oct 8. PMID 24144426
- BACKGROUNDDesiato V, Melis M, Amato B, Bianco T, Rocca A, Amato M, Quarto G, Benassai G. Minimally invasive radioguided parathyroid surgery: A literature review. Int J Surg. 2016 Apr;28 Suppl 1:S84-93. doi: 10.1016/j.ijsu.2015.12.037. Epub 2015 Dec 23. PMID 26721192
- BACKGROUNDNoureldine SI, Gooi Z, Tufano RP. Minimally invasive parathyroid surgery. Gland Surg. 2015 Oct;4(5):410-9. doi: 10.3978/j.issn.2227-684X.2015.03.07. PMID 26425454
- BACKGROUNDParas C, Keller M, White L, Phay J, Mahadevan-Jansen A. Near-infrared autofluorescence for the detection of parathyroid glands. J Biomed Opt. 2011 Jun;16(6):067012. doi: 10.1117/1.3583571. PMID 21721833
- BACKGROUNDSilver Karcioglu AL, Triponez F, Solorzano CC, Iwata AJ, Abdelhamid Ahmed AH, Almquist M, Angelos P, Benmiloud F, Berber E, Bergenfelz A, Cha J, Colaianni CA, Davies L, Duh QY, Hartl D, Kandil E, Kim WW, Kopp PA, Liddy W, Mahadevan-Jansen A, Lee KD, Mannstadt M, McMullen CP, Shonka DC Jr, Shin JJ, Singer MC, Slough CM, Stack BC Jr, Tearney G, Thomas G, Tolley N, Vidal-Fortuny J, Randolph GW. Emerging Imaging Technologies for Parathyroid Gland Identification and Vascular Assessment in Thyroid Surgery: A Review From the American Head and Neck Society Endocrine Surgery Section. JAMA Otolaryngol Head Neck Surg. 2023 Mar 1;149(3):253-260. doi: 10.1001/jamaoto.2022.4421. PMID 36633855