TERMINATED

Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

It is often challenging to tell apart the parathyroid glands from the surrounding area such as lymph nodes, fat and thyroid tissue. If the surgeons are not able to tell where the parathyroid glands are, they might accidentally be removed or damaged. This can lead to complications such as hypocalcemia (low calcium level) requiring treatment and sometimes lead to longer hospital stay. This study is designed to test a new method (a non-invasive hand-held imaging device) to assist surgeons in identifying the parathyroid glands, in order to decrease the rate of post-operative complication.

Official Title

Early Feasibility Study on Intraoperative Parathyroid Gland (PTG) Identification Using a Hand-Held Imager (HHI)

Quick Facts

Study Start:2023-09-01
Study Completion:2025-08-28
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:TERMINATED

Study ID

NCT06939946

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Diagnosis of thyroid tumors, or other conditions requiring thyroid surgery where frozen section biopsy of PTGs is deemed necessary under the surgeon's estimation.
  2. * Plan for surgical resection of pathological PTGs.
  3. * Subject age 18 - 70 yo.
  4. * Subject agreement to participate
  1. * Not eligible for endocrine surgeries
  2. * Plan for biopsy only of thyroid tumor (likely difficult to obtain sufficient tissue for both pathology analysis and study assessment)
  3. * Subject age younger than 18 yo or older than 70 yo
  4. * Subject refusal to participate
  5. * Subject cognitively impaired and/or unable to provide assent.
  6. * Allergy to indocyanine green and iodine.

Contacts and Locations

Principal Investigator

Kaitlyn Frazier, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: OPTOSURGICAL, LLC

  • Kaitlyn Frazier, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2025-08-28

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2025-08-28

Terms related to this study

Keywords Provided by Researchers

  • Thyroid surgery
  • Parathyroid fluorescence
  • Indocyanine Green

Additional Relevant MeSH Terms

  • Thyroid Disease
  • Thyroid Surgery
  • Parathyroid Gland