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68-Gallium-DOTATATE-PET/CT Imaging for Thyroid Cancer

Phase 2

Recruiting

Led By Joanna Klubo-Gwiezdzinska, M.D.

Research Sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with established thyroid cancer diagnosis presenting with 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)

Patients with MTC or suspected of locally advanced or metastatic MTC with calcitonin level > 500 pg/mL

Must not have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during baseline assessment

Awards & highlights

No Placebo-Only Group

Summary

This trial is for people with thyroid cancer to see if 68Gallium-DOTATATE can help show where the cancer is.

Who is the study for?

This trial is for adults with thyroid cancer that has spread and doesn't respond to radioactive iodine treatment. Participants must have a confirmed diagnosis, show disease progression after RAI therapy, or have high calcitonin levels if they have medullary thyroid cancer.

What is being tested?

Researchers are testing a new imaging method using 68Gallium-DOTATATE-PET/CT scans to detect tumors in patients whose thyroid cancer has become resistant to standard treatments. The study aims to improve tumor detection which could guide future therapies.

What are the potential side effects?

Potential side effects may include reactions related to the IV injection of the tracer compound (like discomfort or bruising), exposure to radiation from PET/CT scans, and possible allergic reactions although specific side effects are not detailed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My thyroid cancer has spread and does not respond to radioactive iodine treatment.

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My calcitonin level is above 500 pg/mL, indicating advanced thyroid cancer.

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My thyroid cancer is not responding to radioactive iodine and has worsened.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious conditions like kidney failure or heart failure.

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I am unable to understand and give consent for my treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during baseline assessment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during baseline assessment

This trial's timeline: 3 weeks for screening, Varies for treatment, and during baseline assessment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Correlation between tumor volume and SUV max for each participant

Maximum standard uptake value (SUVmax) of 68Ga-DOTATATE