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Radioactive Isotope

I-124 PET/CT Dosimetry 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

Age greater than or equal to 18 years of age

Patients with established thyroid cancer diagnosis based on the pathology report reviewed at the National Institutes of Health, who underwent total thyroidectomy +/- neck lymph node dissection as clinically indicated

Must not have

Adults who are incapable of providing informed consent

Patients with RAI-non avid disease documented by negative post-therapy whole body scans performed after previous RAI treatments and not subjected to re-differentiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 9 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the two methods of TSH stimulation (endogenous by thyroid hormone withdrawal leading to hypothyroidism and exogenous by injection of human recombinant TSH) in order to find the appropriate 131-I activity.

Who is the study for?

This trial is for adults over 18 with high-risk differentiated thyroid cancer, who've had a total thyroidectomy and may have distant metastases. They should not be pregnant or lactating, must be able to consent, and cannot have serious conditions like renal failure or non-thyroid cancers. Brain/spine metastasis patients are excluded due to risks from TSH-stimulation.

What is being tested?

The study tests how well I-124 PET/CT dosimetry can predict the effective dose of I-131 therapy in thyroid cancer under two types of TSH stimulation: Thyrogen injections and hormone withdrawal. It's a phase 2 pilot comparing these methods within each patient over five years.

What are the potential side effects?

Potential side effects include reactions related to iodine-based therapies such as nausea, sore throat, swelling at injection sites for Thyrogen, hypothyroid symptoms during hormone withdrawal, and general discomfort from imaging procedures.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I have thyroid cancer, confirmed by NIH, and had my thyroid completely removed.

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I've had a CT or MRI with contrast of my brain and spine to check for cancer spread.

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My scans show my cancer has returned or spread.

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My cancer may have returned or spread, indicated by advanced tumor features or changes in my thyroglobulin levels.

Exclusion Criteria

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

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I am unable to understand or give consent for medical procedures.

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My thyroid cancer does not respond to radioactive iodine treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 9 weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Comparison of the whole body and lesional 124I uptake within each patient prepared for imaging with human recombinant TSH (rhTSH) and thyroid hormone withdrawal (THW)