Imaging Dye for Parathyroid Disease

Overseen by Herbert Chen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: University of Alabama at Birmingham

Disqualifiers: Iodine allergy, Shellfish allergy, Pregnancy

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the drug Indocyanine Green (ICG) for parathyroid disease?

Research shows that Indocyanine Green (ICG) can help doctors see parathyroid glands more clearly during surgery, making it easier to identify and remove them if needed. This technique has been successful in surgeries for conditions like primary hyperparathyroidism, where the parathyroid glands are overactive. ^{1 2 3 4 5}

Is Indocyanine Green (ICG) safe for use in humans?

The provided research articles do not contain specific safety data for Indocyanine Green (ICG), but they discuss safety concerns related to other contrast agents, particularly gadolinium-based ones, which can cause allergic reactions and kidney issues in some patients. ^{6 7 8 9 10}

How does the drug Indocyanine Green differ from other treatments for parathyroid disease?

Indocyanine Green (ICG) is unique because it uses near-infrared fluorescence to help surgeons see and identify parathyroid glands during surgery, which is not a feature of standard treatments. This real-time imaging helps distinguish the parathyroid glands from surrounding tissues, making it easier to locate and remove them accurately. ^{2 4 11 12 13}

Research Team

Herbert Chen, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for adults over 18 who need thyroid or parathyroid surgery. It's not suitable for those with allergies to iodine, shellfish, or indocyanine green, nor for pregnant individuals.

Inclusion Criteria

I am over 18 years old.

Exclusion Criteria

Patients with allergy to indocyanine green

Pregnancy

Patients with iodine or shellfish allergies would be excluded

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo thyroidectomy or parathyroidectomy with the administration of indocyanine green and use of fluorescence imaging

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery, focusing on postoperative hypocalcemia and other complications

4 weeks

Treatment Details

Interventions

• Indocyanine Green (Fluorescence Imaging)

Trial Overview The study tests if using a special dye called indocyanine green and a portable imaging device can help surgeons better identify and protect the parathyroid glands during surgery.

Participant Groups

Group I: Parathyroid patients Experimental Treatment 2 Interventions

patients who require parathyroid identification and preservation during parathyroid surgery maneuver

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

Stryker Nordic

Industry Sponsor

Trials

35

Recruited

4,400+

Findings from Research

Indocyanine green (ICG) enhanced fluorescence imaging is a promising technique for real-time intraoperative imaging, particularly in endocrine surgeries related to the parathyroid glands.

Current literature shows variability in the use of ICG regarding doses and techniques, indicating a need for standardized protocols to optimize its effectiveness in preserving parathyroid function during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of ICG enhanced fluorescence for the evaluation of parathyroid gland preservation. Jitpratoom, P., Anuwong, A.[2020]

Indocyanine green (ICG) fluorescence has a high sensitivity of 93.8% for identifying parathyroid glands during surgery, making it a reliable tool for surgeons.

The use of ICG not only helps in identifying the glands but also predicts postoperative function effectively, with a diagnostic odds ratio of 54.57, indicating a strong correlation between ICG scores and the risk of postoperative hypoparathyroidism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine green fluorescence for parathyroid gland identification and function prediction: Systematic review and meta-analysis. Kim, DH., Kim, SH., Jung, J., et al.[2022]

Indocyanine green (ICG) fluorescence imaging was successfully used in three patients undergoing reoperative neck surgery for primary hyperparathyroidism, allowing for accurate identification and removal of parathyroid glands.

The use of ICG helped distinguish parathyroid glands from surrounding soft tissue, suggesting its potential as a valuable tool for intraoperative guidance in parathyroid surgeries, although further studies are needed for first-time surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Indocyanine Green Fluorescence Imaging for Intraoperative Localization in Reoperative Parathyroid Surgery. Sound, S., Okoh, A., Yigitbas, H., et al.[2022]

Intravenous contrast agents, used in imaging procedures like MRI and CT scans, have a low incidence of adverse events, but clinicians must be prepared to manage reactions effectively.

The review highlights various potential adverse events associated with iodinated and gadolinium-based contrast agents, including allergic reactions and nephrotoxicity, emphasizing the importance of risk assessment and premedication strategies for at-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intravenous Imaging Contrast Media Complications: The Basics That Every Clinician Needs to Know. Rose, TA., Choi, JW.[2022]

Gadolinium-based contrast agents are generally very safe, with a low incidence of immediate adverse events reported over the past 10 years, particularly in abdominal MRI procedures, which had the highest rate of 0.013%.

Among the different agents, gadobenate dimeglumine was associated with more severe reactions, including fatalities, suggesting that nonionic linear agents and gadopentetate dimeglumine may have a better safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence of immediate gadolinium contrast media reactions. Prince, MR., Zhang, H., Zou, Z., et al.[2022]

Gadoxetic acid, a gadolinium-based contrast agent, showed a low incidence of hypersensitivity reactions (0.3%) in 14,850 administrations, with no reported deaths, indicating a favorable safety profile.

The risk of nephrogenic systemic fibrosis (NSF) in patients with severe kidney impairment remains uncertain, with an upper bound estimate of 2.8% based on limited data, suggesting more research is needed to fully understand this risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events to the Gadolinium-based Contrast Agent Gadoxetic Acid: Systematic Review and Meta-Analysis. Schieda, N., van der Pol, CB., Walker, D., et al.[2020]

In a study of 32,659 MRI administrations, the overall rate of acute adverse reactions to gadolinium-based contrast agents was low at 0.16%, with 51 reactions reported among 50 patients.

Gadopentetate dimeglumine had a slightly lower adverse reaction rate (0.14%) compared to gadobenate dimeglumine (0.28%), with most reactions being mild, although two severe reactions were associated with gadobenate dimeglumine.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse reactions to gadopentetate dimeglumine and gadobenate dimeglumine: experience with 32,659 injections. Abujudeh, HH., Kosaraju, VK., Kaewlai, R.[2022]

Gadolinium-based MRI contrast agents, once thought safe, have been linked to serious complications like acute renal failure and nephrogenic systemic fibrosis in patients with end-stage renal disease (ESRD), leading to restrictions on their use in these high-risk groups.

The editorial emphasizes the need for careful monitoring and documentation of adverse events related to Gad-CAs, as well as collaboration among medical professionals to manage and mitigate risks associated with their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Good MRI images: to Gad or not to Gad? Steen, H., Schwenger, V.[2019]

Indocyanine green (ICG) NIR fluorescent imaging effectively visualized the parathyroid glands in a study involving three dogs, suggesting its potential utility in surgical procedures like thyroidectomies.

The optimal dose for ICG was estimated to be 18.75 µg/kg, with fluorescence detectable for about 106.7 seconds post-injection, indicating that ICG can help surgeons identify parathyroid glands during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indocyanine green as a near-infrared fluorescent agent for identifying parathyroid glands during thyroid surgery in dogs. Suh, YJ., Choi, JY., Chai, YJ., et al.[2019]

In a study of 66 patients undergoing parathyroidectomy, fluorescence angiography using indocyanine green (ICG) dye demonstrated a rapid average time to peak fluorescence of 38.0 seconds, indicating its effectiveness for real-time identification of parathyroid adenomas.

The in-situ fluorescence rate was high at 97%, suggesting that ICG FA is a reliable tool during surgery, especially when compared to traditional imaging methods, which had lower detection rates for adenomas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid intraoperative perfusion assessment of parathyroid adenomas with ICG using a wide-field portable hand-held fluorescence imaging system. Matson, J., Lwin, TM., Bouvet, M.[2022]

Indocyanine green (ICG) near-infrared fluorescent imaging was effective in localizing parathyroid glands during surgery for primary hyperparathyroidism, with 92.9% of identified glands showing ICG uptake in a study of 33 patients.

All patients achieved a biochemical cure after surgery, and there were no cases of postoperative hypoparathyroidism among those who underwent subtotal parathyroidectomy, indicating the safety of ICG use in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of indocyanine green near infrared fluorescent imaging in the identification of parathyroid glands during surgery for primary hyperparathyroidism. Zaidi, N., Bucak, E., Okoh, A., et al.[2017]

References

1. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

The use of ICG enhanced fluorescence for the evaluation of parathyroid gland preservation. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Use of Indocyanine Green and Fluorescence Angiography in Parathyroid Surgery: A Feasibility Study. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Indocyanine green fluorescence for parathyroid gland identification and function prediction: Systematic review and meta-analysis. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Utility of Indocyanine Green Fluorescence Imaging for Intraoperative Localization in Reoperative Parathyroid Surgery. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Feasibility of indocyanine green fluorescence imaging for intraoperative identification of parathyroid glands during thyroid surgery. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Intravenous Imaging Contrast Media Complications: The Basics That Every Clinician Needs to Know. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Incidence of immediate gadolinium contrast media reactions. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Adverse Events to the Gadolinium-based Contrast Agent Gadoxetic Acid: Systematic Review and Meta-Analysis. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Acute adverse reactions to gadopentetate dimeglumine and gadobenate dimeglumine: experience with 32,659 injections. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Good MRI images: to Gad or not to Gad? [2019]

11. Germany pubmed.ncbi.nlm.nih.gov

Indocyanine green as a near-infrared fluorescent agent for identifying parathyroid glands during thyroid surgery in dogs. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Rapid intraoperative perfusion assessment of parathyroid adenomas with ICG using a wide-field portable hand-held fluorescence imaging system. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

The utility of indocyanine green near infrared fluorescent imaging in the identification of parathyroid glands during surgery for primary hyperparathyroidism. [2017]