Using a hand-held imager to identify parathyroid glands during thyroid surgery
Early Feasibility Study on Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)
This study is testing a new hand-held imaging device to help surgeons find parathyroid glands during thyroid surgery to reduce the risk of complications.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Optosurgical, LLC Industry-sponsored |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT06939946 on ClinicalTrials.gov |
What this trial studies
This study evaluates a new non-invasive hand-held imaging device designed to assist surgeons in identifying parathyroid glands during thyroid surgeries. The device utilizes Near-Infrared Autofluorescence Imaging (NIRAF) to detect spontaneous autofluorescence signals, allowing for better differentiation of parathyroid glands from surrounding tissues. By improving the identification of these glands, the study aims to reduce the risk of complications such as postoperative hypocalcemia. Participants will undergo thyroid surgery where the device will be tested to assess its effectiveness in real-time surgical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of thyroid tumors or conditions requiring thyroid surgery where parathyroid gland assessment is necessary.
Not a fit: Patients who are not eligible for endocrine surgeries or those undergoing biopsy only of thyroid tumors may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative complications related to parathyroid gland injury during thyroid surgeries.
How similar studies have performed: While the use of imaging technology in surgery is not novel, this specific application of a hand-held imager for parathyroid identification is relatively untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of thyroid tumors, or other conditions requiring thyroid surgery where frozen section biopsy of PTGs is deemed necessary under the surgeon's estimation. * Plan for surgical resection of pathological PTGs. * Subject age 18 - 70 yo. * Subject agreement to participate Exclusion Criteria: * Not eligible for endocrine surgeries * Plan for biopsy only of thyroid tumor (likely difficult to obtain sufficient tissue for both pathology analysis and study assessment) * Subject age younger than 18 yo or older than 70 yo * Subject refusal to participate * Subject cognitively impaired and/or unable to provide assent. * Allergy to indocyanine green and iodine.
Where this trial is running
Baltimore, Maryland
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Kaitlyn Frazier, MD — Johns Hopkins University
- Study coordinator: Kaitlyn Frazier, MD
- Email: kfrazier@jhmi.edu
- Phone: 410-955-6420
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.