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

Primary Purpose

Metastic Thyroid Cancer

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
68-Gallium-DOTATATE-PET/CT
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Metastic Thyroid Cancer focused on measuring Thyroid Cancer, Metastases, Ga68-DOTATATE, Somatostatin Receptors, Positron Emission Tomography

Eligibility Criteria

18 Years - 98 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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 or 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 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
  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.

Sites / Locations

  • National Institutes of Health Clinical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Differentiated thyroid cancer (DTC)

Hurthle cell thyroid cancer (HTC)

Medullary thyroid cancer (MTC)

Arm Description

Patients with DTC but not HTC

Molecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC),

Patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
June 15, 2021
Last Updated
October 5, 2023
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04927416
Brief Title
The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
Official Title
The Role of 68-Gallium-DOTATATE-PET/CT in the Imaging of Metastatic Thyroid Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 31, 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
November 30, 2030 (Anticipated)
Study Completion Date
November 30, 2030 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastic Thyroid Cancer
Keywords
Thyroid Cancer, Metastases, Ga68-DOTATATE, Somatostatin Receptors, Positron Emission Tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Differentiated thyroid cancer (DTC)
Arm Type
Experimental
Arm Description
Patients with DTC but not HTC
Arm Title
Hurthle cell thyroid cancer (HTC)
Arm Type
Experimental
Arm Description
Molecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC),
Arm Title
Medullary thyroid cancer (MTC)
Arm Type
Experimental
Arm Description
Patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC)
Intervention Type
Drug
Intervention Name(s)
68-Gallium-DOTATATE-PET/CT
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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
Secondary Outcome Measure Information:
Title
Correlation between tumor volume and SUV max for each participant
Description
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
Title
Maximum standard uptake value (SUVmax) of 68Ga-DOTATATE
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
98 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 [123]I or [131]I diagnostic or post-treatment whole body scan (WBS) 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. EXCLUSION CRITERIA: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Padmasree Veeraraghavan, N.P.
Phone
(301) 451-7710
Email
padmasree.veeraraghavan@nih.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Joanna Klubo-Gwiezdzinska, M.D.
Phone
(301) 496-5052
Email
joanna.klubo-gwiezdzinska@nih.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joanna Klubo-Gwiezdzinska, M.D.
Organizational Affiliation
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
Phone
800-411-1222
Ext
TTY8664111010
Email
prpl@cc.nih.gov

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
.Subject level data will be shared upon request after appropriate collaboration agreements are in place.
Links:
URL
https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_000079-DK.html
Description
NIH Clinical Center Detailed Web Page

Learn more about this trial

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

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