The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
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.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 54 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
Estimated Study Start Date: June 24, 2021
Estimated Primary Completion Date: November 30, 2030
Estimated Study Completion Date: November 30, 2030
Arm:
- Experimental: Differentiated thyroid cancer (DTC)
- Experimental: Hurthle cell thyroid cancer (HTC)
- Experimental: Medullary thyroid cancer (MTC)
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Estimated enrolment | 54 |
| Estimated Study start date | 24 June 2021 |
| Estimated Study Completion Date | 30 November 2030 |