A Phase 2 interventional study of 68-Gallium-DOTATATE-PET/CT in Metastic Thyroid Cancer, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Recruiting at 1 site in United States. Open to participants aged 18 Years to 98 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Phase 2, Interventional, and Diagnostic
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.
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:
Secondary Objectives:
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:
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's planned enrollment of 54 is close to the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is the lead sponsor of 538 studies on the registry; 55 are open to participants now.
Of its 80 completed or terminated interventional studies of FDA-regulated products, 51 (64%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Data prospectively collected from the 28 subjects enrolled under this protocol, and data from 26 subjects collected under 77-DK-0096 and/or 00-CH-0093 will be analyzed. Among the 26 subjects prospectively evaluated under 77-DK-0096 protocol, 21 out of 26 had research 68Ga-DOTATATE PET/CT performed under the DOTATATE sub-study of 77-DK-0096, and 5 out of 26 had 68Ga-DOTATATE PET/CT done under 00-CH-0093. Again, the inclusion of the above data was per the IRB s request to transition the sub-study into a new standalone protocol. This will give us a total of 54 subjects for the final analyses, with at least 18 subjects from each group (e.g., HTC, DTC, and MTC), which is required to meet the primary objectives of this study with sufficient power of 80% and type 1 error alpha of \< 0.05.
Patients with HTC, DTC, and MTC will be identified by the investigators. The potential candidates for the study will be screened for eligibility to participate in the study and invited to sign the Research 68Ga-DOTATATE PET/CT imaging form. The same inclusion/exclusion criteria were applied to the subjects who underwent imaging with the 68GADOTATATE PET/CT, either under the 77-DK-0096 sub-study or as clinically-indicated imaging under 00-CH-0093.
In order to be eligible to participate in this study, an individual with DTC (including HTC) must meet all of the following criteria:
Patients with established thyroid cancer diagnosis presenting with either:
OR
--Patients with RAI-non-responsive disease, who have the evidence of disease progression defined by 1.1 criteria after therapy with RAI.
In order to be eligible to participate in this study, an individual with MTC must meet all of the following criteria:
EXCLUSION CRITERIA:
Subjects with either HTC, DTC, or MTC who meet any of the following criteria will be excluded from participation in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with DTC but not HTC
Drug: 68-Gallium-DOTATATE-PET/CT
Molecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC),
Drug: 68-Gallium-DOTATATE-PET/CT
Patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC)
Drug: 68-Gallium-DOTATATE-PET/CT
68Ga-DOTATATE is administered one-time via intravenous injection of 5 mCi in a volume of 3-5 ml containing up to 50 mcg \[68Ga\] DOTATATE.
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
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.
Time frame: During baseline assessment
Correlation between tumor volume and SUV max for each participant
Tumor volume in cm3 as measured by the ellipsoid formula will be measured on up to 10 lesions per organ and correlated with SUVMax
Time frame: During baseline assessment
Maximum standard uptake value (SUVmax) of 68Ga-DOTATATE
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.
Time frame: During baseline assessment
Plan to share: No — Subject level data will be shared upon request after appropriate collaboration agreements are in place.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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