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Parathyroid DysfunctionPhase 4NCT06169735

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

A Phase 4 study testing Indocyanine green and SPY Portable Handheld Imaging in people with Parathyroid Dysfunction and Adenoma, run by University of Alabama at Birmingham at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Parathyroid Dysfunction, Adenoma
What is being tested?
Indocyanine green and SPY Portable Handheld Imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
417 participants
Where
1 siteUnited States
Study dates
11 Apr 2024to 5 May 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • age greater than 18 years old

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UAB Callahan Eye

    Birmingham, Alabama, 35233

Other trials in United States

About this study

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

Read the 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.

Being tested
Indocyanine green, SPY Portable Handheld Imaging
Keywords
Indocyanine Green, Parathyroid Surgery
Medical subject headings
Parathyroid Diseases, Adenoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine greenDrug

    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 ImagingDevice

    Also called SPY-PHI

    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

Study groups in NCT06169735
Study groupRoleWhat they receive
Parathyroid patientsExperimentalpatients who require parathyroid identification and preservation during parathyroid surgery maneuver
Receives: Drug: Indocyanine green; Device: SPY Portable Handheld Imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2023
  2. Study start11 Apr 2024
  3. Primary completion5 May 2026
  4. Study completion5 May 2026

Why it stopped: Funding halted

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Model description
This is already a pre-approved drug by FDA.
Masking
None (open label)
Enrolment
417 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06169735
Sponsor's protocol ID
IRB-300011872
Other IDs
Stryker
Status last verified
May 2026
First submitted
5 Dec 2023
Last updated
6 May 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 24402815

  • 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.

    PubMed 24144426

  • 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.

    PubMed 26721192

  • 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.

    PubMed 26425454

  • 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.

    PubMed 21721833

  • 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.

    PubMed 36633855

  • 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.

    PubMed 27797004

  • 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.

    PubMed 29129358

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Indocyanine green and SPY Portable Handheld Imaging in people with Parathyroid Dysfunction and Adenoma, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Funding halted). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Parathyroid Glands identified by ICG (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06169735, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026.

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