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

NCT ID: NCT06169735

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 417 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-11
• Study Completion Date: 2026-05-01

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.

Detailed Description

The accurate identification of the parathyroid gland is a crucial aspect of thyroid and parathyroid surgery. Failing to recognize the parathyroid gland during thyroidectomy can result in the inadvertent removal of the gland, leading to postoperative hypocalcemia. On the other hand, during parathyroidectomy, there is a risk of mistaking other structures, such as lymph nodes, for parathyroid adenomas, which can leave the patient without a cure. Currently UAB employs intraoperative PTH or radioactive isotope techniques in conjunction with surgeon judgment. However, both methods have limitations, including being time-consuming, posing logistical challenges, and not providing feedback before gland removal.

Parathyroid fluorescence is a relatively new technology. It was initially discovered that the parathyroid gland emits fluorescence, which distinguishes it from the surrounding tissues. Additionally, indocyanine green dye is readily taken up by the parathyroid gland, making its detection easy to the naked eye. Research has demonstrated that parathyroid fluorescence, with or without indocyanine green, is not only safe but also helps reduce postoperative hypocalcemia and locate lesions in patients with imaging-negative parathyroid adenomas. However, the current use of parathyroid fluorescence is not standardized, and further studies are needed to explore its clinical utility in terms of cure rates and postoperative complications.

Conditions

Parathyroid Dysfunction; Adenoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Parathyroid patients

patients who require parathyroid identification and preservation during parathyroid surgery maneuver

Group Type: EXPERIMENTAL

Indocyanine green

Intervention Type: 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.

SPY Portable Handheld Imaging

Intervention Type: 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

Interventions

Indocyanine green

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.

Intervention Type: DRUG

SPY Portable Handheld Imaging

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

Intervention Type: DEVICE

Other Intervention Names

SPY-PHI

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stryker Nordic

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Herbert Chen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Herbert Chen, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Callahan Eye

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Niranjna Swaminathan, MD

Role: CONTACT

nswaminathan@uabmc.edu

2059297195

Azeem Izhar, MD

Role: CONTACT

aizhar@uabmc.edu

6592028958

Facility Contacts

Niranjna Swaminathan, MD

Role: primary

nswaminathan@uabmc.edu

2059297195

Azeem Izhar, MD

Role: backup

aizhar@uabmc.edu

6592028958

References

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.

Reference Type: BACKGROUND

PMID: 24402815 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24144426 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26721192 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26425454 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21721833 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 36633855 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27797004 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29129358 (View on PubMed)

Other Identifiers

Stryker

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-300011872

Identifier Type: -

Identifier Source: org_study_id