Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation

NCT06169735 | Terminated Phase 4 FDA Drug FDA Device

• 2 other identifiers: IRB-300011872Stryker
• Study Type: interventional
• Target: 417
• Locations: 1 country
• Sites: 1

Brief Summary

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

Parathyroid Dysfunction; Adenoma

Keywords

Indocyanine Green; Parathyroid Surgery

Outcome Measures

Primary Outcomes (1)

• Percentage of Parathyroid Glands identified by ICG

  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.

  20 minutes

Study Arms (1)

Parathyroid patients

EXPERIMENTAL

patients who require parathyroid identification and preservation during parathyroid surgery maneuver

Drug: Indocyanine green; Device: SPY Portable Handheld Imaging

Interventions

Indocyanine green DRUG

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.

Parathyroid patients

SPY Portable Handheld Imaging DEVICE

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

Also known as: SPY-PHI

Parathyroid patients

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age greater than 18 years old

You may not qualify if:

• Patients with iodine or shellfish allergies would be excluded.
• Patients with allergy to indocyanine green.
• Pregnancy

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Stryker Nordic: collaborator

Study Sites (1)

UAB Callahan Eye

Birmingham, Alabama, 35233, United States

Location

Related Publications (8)

• Edafe 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 BACKGROUND

• Carter 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 BACKGROUND

• Desiato 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 BACKGROUND

• Noureldine 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 BACKGROUND

• Paras 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 BACKGROUND

• Silver 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 BACKGROUND

• Chernock RD, Jackson RS. Novel Cause of 'Black Thyroid': Intraoperative Use of Indocyanine Green. Endocr Pathol. 2017 Sep;28(3):244-246. doi: 10.1007/s12022-016-9458-z.

  PMID: 27797004 BACKGROUND

• DeLong JC, Ward EP, Lwin TM, Brumund KT, Kelly KJ, Horgan S, Bouvet M. Indocyanine green fluorescence-guided parathyroidectomy for primary hyperparathyroidism. Surgery. 2018 Feb;163(2):388-392. doi: 10.1016/j.surg.2017.08.018. Epub 2017 Nov 10.

  PMID: 29129358 BACKGROUND

MeSH Terms

Conditions

Parathyroid Diseases; Adenoma

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Herbert Chen, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is already a pre-approved drug by FDA.

Study Record Dates

• First Submitted: December 5, 2023
• First Posted: December 13, 2023
• Study Start: April 11, 2024
• Primary Completion: May 5, 2026
• Study Completion: May 5, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)