The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer

  • STATUS
    Recruiting
  • End date
    Nov 30, 2030
  • participants needed
    54
  • sponsor
    National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Updated on 4 October 2022

Summary

Background

About 5% to 10% of differentiated thyroid cancers become resistant to standard treatment with radioactive iodine. In these cases, treatment options are limited and generally not effective. Researchers want to see if they can better detect thyroid tumors by using a compound called 68Gallium-DOTATATE. This compound may bind to a tumor and make it visible during a positron emission tomography/computed tomography (PET/CT) scan. This information might help guide future research and treatment.

Objective

To identify the people with thyroid cancer whose tumors have a high uptake of 68Gallium-DOTATATE as analyzed by imaging with PET/CT.

Eligibility

People ages 18 years and older with thyroid cancer that has spread outside of the thyroid.

Design

Participants will have a medical exam. They will give blood and urine samples. Some samples will be used for research.

Participants will have imaging scans that follow standard of care. These scans may include:

CT scan of the neck, chest, abdomen, and pelvis

Bone scan

Magnetic resonance imaging of the brain, spine, or liver

18-FDG-PET/CT as needed

Participants will have a PET/CT scan. They will get an intravenous (IV) line. They will get an IV injection of 68Gallium-DOTATATE. It contains radioactive tracers. The PET/CT scanner is shaped like a large donut. It contains crystals. The crystals pick up small radiation signals that are given off by the tracers. The CT part of the scan uses low-dose x-rays. The pictures made by the scanner show where the tracers are in the body. The session will last 90 minutes.

Participation will last for about 3 months.

Description

The study is designed to identify the patients with metastatic radioactive iodine (RAI) non-avid or non-responsive thyroid cancer RAI non-responsive Hurthle cell thyroid cancer (HTC), differentiated thyroid cancer (DTC) and metastatic medullary thyroid cancer (MTC), whose tumors are

characterized by a high expression of somatostatin receptors type 2 (SSTR2) by a one-time experimental imaging using 68Gallium(68Ga)-DOTATATE Positron Emission Tomography/Computed Tomography (PET/CT) scan. Participants will also undergo standard of care imaging per ATA

guidelines. Both the experimental 68Ga-DOTATATE PET/CT scan and the standard of care imaging will be performed within a 3 month timeframe.

The main goal is to compare the prevalence of patients with metastatic RAI-non-avid or RAI-non-responsive thyroid cancer whose tumors are characterized by a high SSTR2 expression by imaging with 68Ga-DOTATATE PET/CT between three groups: (1) Group HTC - the molecularly and

histologically unique subtype of differentiated thyroid cancer (DTC) - Hurthle cell thyroid cancer (HTC), (2) Group DTC - patients with remaining histological types of DTC, and (3) Group MTC -- patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer

(MTC). The Second goal of this study is to analyze the associate between the 68Ga-DOTATATE uptake and molecular signature of thryoid cancer and tumor volume, and to create a repository of data for future research in thyroid cancer.

Details
Condition Metastic Thyroid Cancer
Treatment 68-Gallium-DOTATATE-PET/CT
Clinical Study IdentifierNCT04927416
SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last Modified on4 October 2022

Eligibility

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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