This is the classic website, which will be retired eventually. Please visit the modernized ClinicalTrials.gov instead.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04927416
Recruitment Status : Recruiting
First Posted : June 16, 2021
Last Update Posted : September 29, 2023
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Metastic Thyroid Cancer Drug: 68-Gallium-DOTATATE-PET/CT Phase 2

Detailed 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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Actual Study Start Date : October 25, 2021
Estimated Primary Completion Date : November 30, 2030
Estimated Study Completion Date : November 30, 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Differentiated thyroid cancer (DTC)
Patients with DTC but not HTC
 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.
Experimental: Hurthle cell thyroid cancer (HTC)
Molecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC),
 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.
Experimental: Medullary thyroid cancer (MTC)
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Correlation between tumor volume and SUV max for each participant [ Time Frame: 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

  2. Maximum standard uptake value (SUVmax) of 68Ga-DOTATATE [ Time Frame: 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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 98 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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 68Gallium-DOTATATE PET/CT imaging informed consent form

In order to be eligible to participate in this study, an individual with DTC (including HTC) must meet all of the following criteria:

  1. Male or female, aged >=18 years.

  2. Patients with established thyroid cancer diagnosis presenting with either:

    1. Locally advanced or distant metastases, which are RAI-non-avid based on the [123]I or [131]I diagnostic or post-treatment whole body scan (WBS) OR
    2. 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:

  1. Male or female, aged >=18 years.
  2. Patients with locally advanced or metastatic MTC or patients suspected of locally advanced or metastatic MTC with calcitonin level > 500 pg/mL.

EXCLUSION CRITERIA:

Subjects with either HTC, DTC, or MTC who meet any of the following criteria will be excluded from participation in this study:

  1. Pregnancy or lactation by self-report.
  2. Serious underlying medical conditions that restrict diagnostic testing or therapy such as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma;
  3. Patients unable to give informed consent.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04927416


Contacts
Layout table for location contacts
Contact: Padmasree Veeraraghavan, N.P. (301) 451-7710 padmasree.veeraraghavan@nih.gov
Contact: Joanna Klubo-Gwiezdzinska, M.D. (301) 496-5052 joanna.klubo-gwiezdzinska@nih.gov

Locations
Layout table for location information
United States, Maryland
National Institutes of Health Clinical Center Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Layout table for investigator information
Principal Investigator: Joanna Klubo-Gwiezdzinska, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier: NCT04927416    
Other Study ID Numbers: 10000079
000079-DK
First Posted: June 16, 2021    Key Record Dates
Last Update Posted: September 29, 2023
Last Verified: August 31, 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: .Subject level data will be shared upon request after appropriate collaboration agreements are in place.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ):
Thyroid Cancer
Metastases
Ga68-DOTATATE
Somatostatin Receptors
Positron Emission Tomography
Additional relevant MeSH terms:
Layout table for MeSH terms
Thyroid Neoplasms
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
 Neoplasms by Site
Neoplasms
Head and Neck Neoplasms