Radioactive Iodine Dosimetry for Thyroid Cancer

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Other active cancers, Anaplastic, Medullary, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6-8 weeks

20 Participants Needed

Trial Summary

What is the purpose of this trial?

One of the most effective treatments for metastases from thyroid cancer is a form of radioactive iodine known as 131-I. For more than 50 years, 131-I has been used to find and destroy thyroid cancer cells that have spread to other parts of the body. In many cases this treatment destroys the metastatic cells. However, in some patients it does not appear to work completely. This study is designed to use a slightly different form of radioactive iodine (called 124-I) which can precisely predict the amount of radiation that each metastatic lesion will receive. 124-I was developed at Memorial Sloan-Kettering in the 1950s and has been used here and at many other medical centers around the world for diagnostic studies. It has been found to be very safe and effective at finding metastatic lesions. The high resolution of newer PET scanners now allows us to carefully determine how much radiation each metastatic lesion will receive. If 124-I can accurately predict which patients will not respond to 131-I treatments we can then avoid exposing those patients to unnecessary radiation. For the rest of the patients we can custom tailor the 131-I dose to destroy the metastatic lesions.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, patients who plan to withdraw from thyroid hormone before dosimetry are not eligible, suggesting that staying on thyroid hormone might be required.

What data supports the effectiveness of the treatment using 124-I and 131-I for thyroid cancer?

Research shows that using 124-I in PET/CT scans helps doctors accurately measure how much radiation a thyroid cancer lesion absorbs, which can guide personalized treatment plans with 131-I. This approach has been shown to improve the safety and effectiveness of radioiodine therapy for thyroid cancer by tailoring the dose to each patient's needs. ^{1 2 3 4 5}

Is radioactive iodine treatment for thyroid cancer safe for humans?

Radioactive iodine treatment, specifically using iodine-131, has been used safely for many years to treat thyroid cancer, but it can cause chromosomal changes in blood cells, especially in patients who receive multiple treatments. While it is generally considered safe, there are potential risks, and safety guidelines are in place to protect patients and those around them. ^{3 6 7 8 9}

How is the treatment 131 I-iodine (131-I) unique for thyroid cancer?

The treatment with 131 I-iodine (131-I) for thyroid cancer is unique because it uses radioactive iodine to target and destroy thyroid cancer cells, particularly after surgery, by taking advantage of the thyroid's natural ability to absorb iodine. This approach allows for individualized dosimetry, which means the radiation dose can be tailored to each patient's needs, potentially improving effectiveness and minimizing side effects. ^{1 2 3 7 10}

Research Team

Ravinder Grewal, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

This trial is for adults with thyroid cancer who've had their thyroid removed and previous treatment to eliminate remaining thyroid tissue. They must have metastases that absorb radioiodine, measurable disease documented in the last six months, and be planning further radioiodine therapy if needed. It's not for those under 18, pregnant, treated with radioiodine in the past nine months, or without metastases.

Inclusion Criteria

You have a documented measurable disease from an ultrasound, MRI, or CT scan within the past six months.

I have thyroid cancer with metastases that respond to radioiodine and am scheduled for a specific diagnostic test at MSKCC.

I am considering 131-I treatment for my thyroid cancer metastases.

Exclusion Criteria

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

You are currently receiving treatment for another type of cancer.

I plan to stop taking thyroid hormone before my dosimetry test.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo diagnostic imaging with 124-I to determine radiation dosage for metastatic lesions

1-2 weeks

Treatment

Participants receive customized 131-I treatment based on 124-I dosimetry results

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• 124 I-iodine (124-I)
• 131 I-iodine (131-I)

Trial Overview The study tests a radioactive iodine form called 124-I to predict radiation doses received by each cancer spread (metastatic lesion) using PET scans. This could help decide if patients will benefit from another type of radioactive iodine treatment (131-I), avoiding unnecessary exposure for non-responders.

Participant Groups

Group I: 1 Experimental Treatment 1 Intervention

131 I-iodine (131-I), 124 I-iodine (124-I)

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Gustave Roussy, Cancer Campus, Grand Paris

Collaborator

Trials

270

Recruited

267,000+

Findings from Research

Radioiodine therapy using 124I PET/CT scans allows for precise estimation of radiation doses to thyroid cancer lesions, improving treatment planning and individualizing therapeutic 131I activity.

This review highlights the importance of 124I in enhancing the accuracy of dosimetry in thyroid cancer treatment, addressing factors that affect PET image quantification and providing a standardized protocol for lesion dosimetry.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of 124I PET/CT lesion dosimetry in differentiated thyroid cancer. Weber, M., Binse, I., Nagarajah, J., et al.[2020]

References

1. Italy pubmed.ncbi.nlm.nih.gov

The role of 124I PET/CT lesion dosimetry in differentiated thyroid cancer. [2020]

2. Spain pubmed.ncbi.nlm.nih.gov

Individualised dosimetry in patients with differentiated thyroid cancer based on external dose-rate. Optimisation of the number of measurements. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Dosimetry and thyroid cancer: the individual dosage of radioiodine. [2011]

4. United States pubmed.ncbi.nlm.nih.gov

Practical dosimetry of 131I in patients with thyroid carcinoma. [2007]

5. Germany pubmed.ncbi.nlm.nih.gov

Lesion-Wise Comparison of Pre-Therapy and Post-Therapy Effective Half-Life of Iodine-131 in Pediatric and Young Adult Patients with Differentiated Thyroid Cancer Undergoing Radioiodine Therapy. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Assessment of radioiodine clearance in patients with differentiated thyroid cancer. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

The evolving role of (131)I for the treatment of differentiated thyroid carcinoma. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Mutagenicity of diagnostic and therapeutical doses of radiopharmaceutical iodine-131 in Wistar rats. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Cytogenetic biodosimetry and dose-rate effect after radioiodine therapy for thyroid cancer. [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Prediction of absorbed dose to normal organs in thyroid cancer patients treated with 131I by use of 124I PET and 3-dimensional internal dosimetry software. [2016]