NIRF for Parathyroid Visualization: a Pilot Study

NCT03012438 | Completed DMC

• 1 other identifier: NL57409.068.16
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

During surgery in which the thyroid is removed (thyroidectomy), the identification of parathyroid glands, that should be saved, can be challenging. Therefore, there is need for accurate intraoperative guidance. Earlier animal studies show that the parathyroid glands can be identified by the use of the Near Infrared Fluorescent dye Indocyanine green (ICG). Our hypothesis is therefore, that the use of ICG-based fluorescence imaging during thyroid surgery will provide real-time intraoperative visualization of the parathyroid glands. This prospective observational feasibility study aims to evaluate the feasibility of the use of ICG in identifying the parathyroid glands during thyroid surgery. 30 patients (age \>18 years) who are already regularly scheduled for thyroid surgery; i.e. patients undergoing total thyroidectomy are suitable for inclusion. In all patients, undergoing total thyroidectomy infrared fluorescence imaging, using a per-operative intravenous injection of 7.5 mg ICG, will be tested on feasibility and imaging characteristics.

Conditions

Thyroid Disease

Keywords

Near infrared fluorescence; ICG; Parathyroid gland

Outcome Measures

Primary Outcomes (1)

• Time to identification of parathyroid glans

  Can the parathyroid glands be identified earlier with NIRF light? Time until identification in NIRF and white light will be compared.

  during surgery

Secondary Outcomes (4)

• Total surgical time

  From incision until closure

• Histology: are parathyroid glands in the specimen? (as in standard care)

  assessment within 1 week after surgery

• Subjective opinion surgeon about the usefulness of the technique

  Immediately after surgery

• Intra-operative complications due to the use of the technique

  during surgery

Other Outcomes (1)

• Quantitative measurement of fluorescence signal related to parathyroid function

  up to 2 weeks

Study Arms (1)

NIRF imaging in thyroid surgery

EXPERIMENTAL

7.5 mg ICG is administered i.v. and the system will be switched to fluorescence mode. If needed, a second dose of 7.5 mg ICG can be administered. After identification of the parathyroid glands, surgery will continue until there is a desire to visualize the parathyroid glands again, another dose of ICG can be given. After complete removal of thyroid, another 7.5 mg of ICG will be given to assess the perfusion of the parathyroid gland. Directly after the procedure the researcher will ask the surgeon whether he/she thinks the technique is feasible. After surgery, the serum calcium levels will be determined in patients after total thyroidectomy on day 1, 2 and after two weeks. TSH will be determined after 2 weeks. The thyroid specimen will be send to pathology. In the specimen, the pathologist will search for parathyroid glands. Video recordings will be analyzed, quantifying the fluorescence signal compared to the background: measuring the TBR.

Device: NIRF imaging in thyroid surgery

Interventions

NIRF imaging in thyroid surgery DEVICE

a fluorescence imaging system and 7.5 mg of ICG will be used to visualize the parathyroids glands.

Also known as: Near Infrared Fluorescence Imaging, Indocyanine green

NIRF imaging in thyroid surgery

Eligibility Criteria

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

You may qualify if:

• Male or female patients, aged 18 years and above
• Scheduled for elective total or hemi thyroidectomy
• Normal liver and renal function
• No known hypersensitivity for iodine or ICG
• Able to understand the nature of the study procedures
• Willing to participate and give written informed consent

You may not qualify if:

• Age \< 18 years
• Liver or renal insufficiency
• Known ICG, iodine, penicillin or sulfa hypersensitivity
• Pregnancy or breastfeeding
• Not able to understand the nature of the study procedure
• i.v. heparin injection in the last 24h (LMWH not contraindicated)
• Not willing to participate

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202, Netherlands

Location

MeSH Terms

Conditions

Thyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

• Nicole Bouvy, M.D. Ph.D.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 6, 2017
• Study Start: March 23, 2017
• Primary Completion: February 1, 2018
• Study Completion: March 12, 2018
• Last Updated: March 14, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)