What side effects are associated with this type of intervention?

The most common treatments for thyroid cancer include radioactive iodine therapy, surgery, and external beam radiotherapy (EBRT). Radioactive iodine therapy, such as Iodine-131, can lead to side effects like dry mouth, nausea, fatigue, altered taste, and an increased risk of developing secondary malignancies such as leukemia and salivary gland cancer. Surgery may result in complications like hypoparathyroidism, vocal cord paralysis, and general surgical risks. EBRT can cause skin irritation, fatigue, and potential damage to surrounding tissues. These treatments aim to eliminate cancer cells but come with varying side effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for thyroid cancer that involve radioactive iodine or similar radiopharmaceuticals. Iodine-131 is commonly used for both diagnostic and therapeutic purposes in thyroid cancer, particularly for ablation of thyroid tissue and treatment of metastatic disease. Additionally, Iodine-131-labeled iobenguane (I-131 MIBG) has been approved for treating certain types of neuroendocrine tumors, which can be relevant for thyroid cancer management. These treatments are designed to target and destroy cancerous thyroid cells by taking advantage of their ability to absorb iodine.

What other types of research exist?

Promising alternatives to Iodine-124 PET imaging for thyroid cancer patients include Iodine-123 diagnostic scanning and 18F-fluorodeoxyglucose (FDG) PET. Iodine-123 offers favorable imaging properties with a lower radiation dose, while FDG-PET is effective for detecting metastatic or recurrent thyroid cancer, particularly in cases with low radioiodine uptake.

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Iodine-124 Imaging for Thyroid Cancer

Phase 1

Recruiting

Led By Ravinder Grewal, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

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

Must have

Adults with thyroid carcinoma confirmed by pathology

Adult thyroid carcinoma patients who have undergone total thyroidectomy

Must not have

Age less than 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging method to see how well cancer cells absorb a special type of iodine. It aims to help doctors decide if patients should continue with their current treatment or switch to a different one based on the scan results. The special iodine has been used to improve accuracy in cancer treatment.

Who is the study for?

This trial is for adults with confirmed thyroid carcinoma who've had their thyroid removed and either have metastatic disease or are suspected to. They should be planning on radioiodine therapy if persistent cancer that absorbs iodine is found, and must have measurable disease documented in the last six months.

What is being tested?

The study tests a new PET scan using radioactive iodine-124 to see how much iodine the cancer takes up. This helps decide if standard radioiodine therapy will work or if another treatment is better. The test could lead to continuing usual treatment or switching strategies based on uptake levels.

What are the potential side effects?

Since this trial focuses on diagnostic imaging rather than a therapeutic intervention, side effects may include discomfort from the PET/CT procedure, potential allergic reactions to contrast agents used during imaging, and exposure to radiation.

Eligibility Criteria

Inclusion Criteria

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

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My thyroid cancer diagnosis is confirmed by a pathology report.

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I had my entire thyroid removed due to cancer.

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I am considering 131I therapy for my thyroid cancer metastases.

Exclusion Criteria

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

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

number of individual lesions response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Lesion Dosimetry With Iodine-124Experimental Treatment2 Interventions

Patients will be administered 124I and undergo serial PET imaging consisting of up to 4 individual PET/CT scans. In order to perform a dual exponential fit, 4 scans are needed to obtain the necessary amount of data points required. Lesion dosimetry shall be performed based on the 124I PET scan data through tumor uptake and clearance pharmacokinetics. 10 patients, who sign consent for the sub-study, will be administered an additional tracer diagnostic activity of 124I (4 to 7 mCi). These patients will then undergo additional (up to a maximum of 4) PET scanning during radioiodine therapy at time points matched, if possible, to the days of the pre-therapy 124I dosimetry study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PET/CT Scan

2013

Completed Phase 2

~1370

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for thyroid cancer include radioactive iodine therapy, surgery, and external beam radiotherapy (EBRT). Radioactive iodine therapy works by using radioactive iodine-131, which is selectively taken up by thyroid cells, including cancerous ones, to destroy them from within. This is particularly effective for differentiated thyroid cancers that absorb iodine. Surgery involves the removal of the thyroid gland (thyroidectomy) and is often the first line of treatment to physically eliminate the tumor. EBRT uses high-energy radiation to target and kill cancer cells, and is typically used when the cancer is not iodine-avid or has spread to surrounding tissues. These treatments are crucial as they offer targeted approaches to eliminate cancer cells, reduce recurrence, and improve survival rates for thyroid cancer patients.

Renal and Red Marrow Dosimetry in Peptide Receptor Radionuclide Therapy: 20 Years of History and Ahead.Clinical translation of theranostic radiopharmaceuticals: Current regulatory status and recent examples.Effects of recombinant human thyroid-stimulating hormone superagonists on thyroidal uptake of 18F-fluorodeoxyglucose and radioiodide.