Metastic Thyroid CancerPhase 2NCT04927416
The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
A Phase 2 study testing 68-Gallium-DOTATATE-PET/CT in people with Metastic Thyroid Cancer, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 98 years
- Conditions the study is for
- Metastic Thyroid Cancer
- What is being tested?
- 68-Gallium-DOTATATE-PET/CT
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Oct 2021to 30 Nov 2030
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 98 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 informed consent 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:
- Male or female, aged >18 years.
- Patients with established thyroid cancer diagnosis presenting with either:
- Locally advanced or distant metastases, which are RAI-non-avid based on the or diagnostic or post-treatment whole body scan (WBS)
Show all 11Show fewer
- OR
- --Patients with RAI-non-responsive disease, who have the evidence of disease progression defined by RECIST 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:
- Male or female, aged >18 years.
- Patients with locally advanced or metastatic MTC or patients suspected of locally advanced or metastatic MTC with calcitonin level > 500 pg/mL.
Who cannot join
- Subjects with either HTC, DTC, or MTC who meet any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation by self-report.
- Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma;
- Patients unable to give informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
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.
Read more
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....
Read the 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:
- To analyze the association between the 68Ga-DOTATATE uptake and molecular signature of thyroid cancer and tumor volume,
- 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:
- Somatic mutation status in primary tumors divided into BRAF-like, RAS-like, harboring mitochondrial DNA mutations and /or RET protooncogene mutation,
- Tumor volume measured in cm3 per the ellipsoid formula p/6 length*width*depth.
- Conditions
- Metastic Thyroid Cancer
- Being tested
- 68-Gallium-DOTATATE-PET/CT
- Keywords
- Thyroid Cancer, Metastases, Ga68-DOTATATE, Somatostatin Receptors, Positron Emission Tomography
- Medical subject headings
- Thyroid Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68-Gallium-DOTATATE-PET/CTDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Differentiated thyroid cancer (DTC) | Experimental | Patients with DTC but not HTC Receives: Drug: 68-Gallium-DOTATATE-PET/CT |
| Hurthle cell thyroid cancer (HTC) | Experimental | Molecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC), Receives: Drug: 68-Gallium-DOTATATE-PET/CT |
| Medullary thyroid cancer (MTC) | Experimental | Patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC) Receives: Drug: 68-Gallium-DOTATATE-PET/CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During baseline assessment
Secondary outcomes (2)
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
Measured: 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.
Measured: During baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start25 Oct 2021
- Primary completion30 Nov 2030 (estimated)
- Study completion30 Nov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastic Thyroid CancerStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Joanna Klubo-Gwiezdzinska, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927416
- Sponsor's protocol ID
- 10000079
- Other IDs
- 000079-DK
- Status last verified
- 1 Oct 2026
- First submitted
- 15 Jun 2021
- Last updated
- 5 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Subject level data will be shared upon request after appropriate collaboration agreements are in place.
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
- ClinicalTrials.gov ID
- NCT04927416
- Acronym / sponsor ID
- 10000079
- Conditions
- Metastic Thyroid Cancer
- Keywords
- Thyroid Cancer, Metastases, Ga68-DOTATATE, Somatostatin Receptors, Positron Emission Tomography
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 30 Nov 2030 (estimated)
- Study completion
- 30 Nov 2030 (estimated)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To analyze the association between the 68Ga-DOTATATE uptake and molecular signature of thyroid cancer and tumor volume,
- 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:
- Somatic mutation status in primary tumors divided into BRAF-like, RAS-like, harboring mitochondrial DNA mutations and /or RET protooncogene mutation,
- Tumor volume measured in cm3 per the ellipsoid formula p/6 length*width*depth.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Differentiated thyroid cancer (DTC) | Experimental | Drug: 68-Gallium-DOTATATE-PET/CTPatients with DTC but not HTC |
| Hurthle cell thyroid cancer (HTC) | Experimental | Drug: 68-Gallium-DOTATATE-PET/CTMolecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC), |
| Medullary thyroid cancer (MTC) | Experimental | Drug: 68-Gallium-DOTATATE-PET/CTPatients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC) |
Who may qualify
- Ages
- 18 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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 informed consent 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:
- Male or female, aged >18 years.
- Patients with established thyroid cancer diagnosis presenting with either:
Key exclusion criteria (4 listed)
- Subjects with either HTC, DTC, or MTC who meet any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation by self-report.
- Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma;
- Patients unable to give informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68-Gallium-DOTATATE-PET/CT68Ga-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. | Drug | Differentiated thyroid cancer (DTC), Hurthle cell thyroid cancer (HTC), Medullary thyroid cancer (MTC) |
Primary outcome
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
Time frame: 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.
2 secondary outcomes
Correlation between tumor volume and SUV max for each participant
Time frame: During baseline assessment
Maximum standard uptake value (SUVmax) of 68Ga-DOTATATE
Time frame: During baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. Subject level data will be shared upon request after appropriate collaboration agreements are in place.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Joanna Klubo-Gwiezdzinska, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 68-Gallium-DOTATATE-PET/CT in people with Metastic Thyroid Cancer, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Padmasree Veeraraghavan, R.N. ((301) 451-7710, padmasree.veeraraghavan@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: During baseline assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.