The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
- Conditions
- Metastic Thyroid Cancer
- Interventions
- Drug: 68-Gallium-DOTATATE-PET/CT
- Registration Number
- NCT04927416
- Brief 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.
- Detailed Description
Study Description:
The study is designed to identify the patients with metastatic radioactive iodine (RAI) non-avid or non-responsive thyroid cancer, whose tumors are characterized by the high expression of somatostatin receptors type 2 (SSTR2) by imaging with 68Gallium(68Ga)-DOTATATE Positron Emission Tomography/Computed Tomography (PET/CT). Participants will undergo a one-time experimental imaging with 68Ga-DOTATATE PET/CT. This imaging will enable identification of patients with high maximum standard uptake value (SUVmax) of 68Ga-DOTATATE defined as SUVmax of \>15, as this SUVmax threshold has been associated with a good response to peptide receptor radionuclide therapy (PRRT) in pre-clinical and clinical models of SSTR2-positive tumors. PRRT will not be offered in this trial.
Objectives:
Primary Objective:
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:
* Group HTC--the molecularly and histologically unique subtype of differentiated thyroid cancer (DTC) - Hurthle cell thyroid cancer (HTC),
* Group DTC--patients with remaining histological types of DTC,
* Group MTC--patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC).
Secondary Objectives:
1. To analyze the association between the 68Ga-DOTATATE uptake and molecular signature of thyroid cancer and tumor volume,
2. to create a repository of data for future research in thyroid cancer.
Endpoints:
Primary Endpoint: Prevalence of thyroid cancer patients characterized by a high SSTR2 expression in at least one metastatic lesions per patient documented by SUVmax of 68Ga-DOTATATEPET/CT of above 15 among patients with metastatic HTC, DTC and MTC.
Secondary Endpoints: Associations between 68Ga-DOTATATE uptake as measured by SUVmax in up to 10 lesions per organ per patient and:
1. Somatic mutation status in primary tumors divided into BRAF-like, RAS-like, harboring mitochondrial DNA mutations and /or RET protooncogene mutation,
2. Tumor volume measured in cm3 per the ellipsoid formula p/6 length\*width\*depth.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Differentiated thyroid cancer (DTC) 68-Gallium-DOTATATE-PET/CT Patients with DTC but not HTC Hurthle cell thyroid cancer (HTC) 68-Gallium-DOTATATE-PET/CT Molecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC), Medullary thyroid cancer (MTC) 68-Gallium-DOTATATE-PET/CT Patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC)
- Primary Outcome Measures
Name Time Method 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 During baseline assessment Prevalence of thyroid cancer patients characterized by a high SSTR2 expression in at least one metastatic lesion per patient documented by SUVmax of 68Ga-DOTATATE-PET/CT of above 15 among patients with metastatic HTC, DTC and MTC.
- Secondary Outcome Measures
Name Time Method Correlation between tumor volume and SUV max for each participant During baseline assessment Tumor volume in cm3 as measured by the ellipsoid formula will be measured on up to 10 lesions per organ and correlated with SUVMax
Maximum standard uptake value (SUVmax) of 68Ga-DOTATATE During baseline assessment SUVmax will be compared in groups based on the somatic mutation status in primary tumors: BRAF-like, RAS-like, harboring mitochondrial DNA mutations and /or RET protooncogene mutation.
Related Research Topics
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Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States
National Institutes of Health Clinical Center🇺🇸Bethesda, Maryland, United StatesFor more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)Contact800-411-1222prpl@cc.nih.gov