Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma

RecruitingOBSERVATIONAL
Enrollment

250

Participants

Timeline

Start Date

October 6, 2021

Primary Completion Date

December 31, 2024

Study Completion Date

December 31, 2024

Conditions
Differentiated Thyroid CancerLymph Node Metastases
Interventions
DEVICE

Point of care assay for thyroglobulin (POC-Tg) evaluation of a suspected cervical lymph node

"FNA Clinic: When a bloody material is seen in the needle, 100 µL of 0.9% saline is drawn via the needle into the syringe. The aspirate is then transferred into an Eppendorf tube. 40 µL is aspirated from the Eppendorf tube and dripped into the middle of the sample well of the POC-Tg kit. Two drops of the buffer are then dispensed into the middle of the sample well. The result of the POC-Tg is obtained and documented after 10 minutes. To compare the accuracy of the POC-Tg kit to the formal immunoassay for Tg, 0.9% saline is added to the aspirate that was left in the Eppendorf tube to a final volume of 0.6 mL. This volume is transferred into a gel containing tube and sent to the clinical laboratory that performs Tg measurement.~Operating room: When an indeterminate or suspicious LN is found, the LN is dissected and evaluated by both the formal evaluation and the POC-Tg. Following dissection of the LN, the ex-vivo POC-Tg is conducted as described above."

Trial Locations (5)

52621

RECRUITING

Sheba Medical Center, Ramat Gan

69710

RECRUITING

A.R.M Medical Center, Assuta Ramat Hahayal, Tel Aviv

84101

RECRUITING

Soroka University Medical Center, Beersheba

Unknown

RECRUITING

Barzilai Medical Center, Ashkelon

RECRUITING

Hebrew University Medical Center, Mount Scopus, Jerusalem

All Listed Sponsors
lead

Soroka University Medical Center

OTHER