NCT03969108

Brief Summary

This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 31, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 6, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 12, 2019

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2019

Completed
Last Updated

March 27, 2020

Status Verified

March 1, 2020

Enrollment Period

3 months

First QC Date

May 24, 2019

Last Update Submit

March 26, 2020

Conditions

Thyroid CancerThyroid GoiterGraves Disease

Keywords

Thyroid surgeryIndocyanine green (ICG)Hypoparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Quantification of the fluorescent signal of ICG

    Quantification of the fluorescent signal of ICG

    At time of surgery

Secondary Outcomes (6)

  • Appearance of parathyroid gland

    At time of surgery

  • Duration of surgery

    From start to end of surgery

  • Postoperative calcium concentration

    Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)

  • Postoperative PTH concentration

    Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)

  • Rate of prescribed postoperative calcium medication

    Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)

  • +1 more secondary outcomes

Study Arms (1)

Indocyanine Green

EXPERIMENTAL
Drug: Indocyanine Green

Interventions

Indocyanine GreenDRUG

ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.

Indocyanine Green

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ≥ 18 years
  • Patients undergoing total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter
  • Patients are eligible for surgery
  • Patients are mentally competent and are able and willing to comply with study procedures
  • Written informed consent

You may not qualify if:

  • Patients with a known allergy to ICG or iodinated contrast
  • Pregnant or lactating women
  • Patients with previous neck surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Thyroid NeoplasmsGoiterGraves DiseaseHypoparathyroidism

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid DiseasesExophthalmosOrbital DiseasesEye DiseasesHyperthyroidismAutoimmune DiseasesImmune System DiseasesParathyroid Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Jesse Pasternak, MD, MPHc

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2019

First Posted

May 31, 2019

Study Start

August 6, 2019

Primary Completion

November 12, 2019

Study Completion

November 13, 2019

Last Updated

March 27, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)