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

Conditions

• Metastic Thyroid Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - 98 Years

Healthy Volunteers

Not accepted

Interventions

• 68-Gallium-DOTATATE-PET/CT — DRUG
  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 Details

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.

Key Dates

Start date

Oct 25, 2021

Status verified

May 2026

Primary completion

Nov 30, 2030

Completion

Nov 30, 2030

Study Design

Enrollment

54 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Differentiated thyroid cancer (DTC)
  Patients with DTC but not HTC
• Experimental: Hurthle cell thyroid cancer (HTC)
  Molecularly and histologically unique subtype of DTC - Hurthle cell thyroid cancer (HTC),
• Experimental: Medullary thyroid cancer (MTC)
  Patients with metastatic thyroid cancer of neuroendocrine origin - medullary thyroid cancer (MTC)

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 ]

Central Contacts

• Padmasree Veeraraghavan, R.N.
  (301) 451-7710
  [email protected]
• Joanna Klubo-Gwiezdzinska, M.D.
  (301) 496-5052
  [email protected]

Locations (1)

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