Iodine-124 Imaging for Thyroid Cancer

Recruiting at1 trial location

Overseen by Ravinder Grewal, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Age less than 18, Pregnancy

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Iodine-124 Imaging for Thyroid Cancer?

Iodine-124 imaging, used with PET/CT scans, helps in better detecting and managing thyroid cancer by providing clearer images of cancer spread and measuring how much iodine the cancer cells take up. This can improve treatment decisions and outcomes by tailoring therapy to individual needs. ^{1 2 3 4 5}

Is Iodine-124 imaging safe for humans?

Iodine-124 imaging, used in PET/CT scans, is generally considered safe for humans, but it emits radiation that can pose a risk to healthcare workers, so safety measures are important. The imaging technique is used to improve diagnosis and treatment planning for thyroid cancer, and while it has been studied more in adults, there is limited safety data available for children. ^{2 3 6 7 8}

How does Iodine-124 imaging differ from other treatments for thyroid cancer?

Iodine-124 imaging is unique because it uses a special type of scan called PET/CT to provide detailed images of thyroid cancer, helping to better detect and stage the disease. This method allows for more precise measurement of iodine uptake, which can guide personalized treatment plans and improve the accuracy of radiation dosimetry compared to traditional methods. ^{2 3 5 7 9}

Research Team

Ravinder Grewal, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

My disease can be measured and has been documented within the last 6 months.

My thyroid cancer diagnosis is confirmed by a pathology report.

I have thyroid cancer that may have spread, or I'm getting treatment to help my body absorb radioactive iodine.

Exclusion Criteria

Patients who are pregnant

I am under 18 years old.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lesion Dosimetry

Patients will be administered 124I and undergo serial PET imaging consisting of up to 4 individual PET/CT scans to evaluate iodine uptake in cancer lesions.

4-6 weeks

Up to 4 visits (in-person)

Treatment

Based on PET scan results, patients may continue with radioiodine therapy or switch to another form of therapy if uptake is low.

Variable

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• Iodine-124 (Radioactive Agent)
• PET/CT Scan (Procedure)

Trial Overview 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.

Participant Groups

Group I: Lesion Dosimetry With Iodine-124 Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Lisa M. DeAngelis

Memorial Sloan Kettering Cancer Center

Chief Medical Officer since 2021

MD from Columbia University

Selwyn M. Vickers

Memorial Sloan Kettering Cancer Center

Chief Executive Officer since 2022

MD from Johns Hopkins University

Findings from Research

Iodine-124 PET is an effective imaging technique for diagnosing thyroid diseases, but it can be challenging to interpret due to the lack of clear anatomical structures.

Using a combined PET/CT scanner enhances the accuracy of imaging by correlating functional and anatomical data, which can lead to changes in patient treatment plans based on the imaging results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined PET/CT with iodine-124 in diagnosis of spread metastatic thyroid carcinoma: a case report. Freudenberg, LS., Antoch, G., Görges, R., et al.[2020]

Iodine-124 PET/CT significantly enhances the diagnosis and treatment of thyroid cancer by improving the staging of patients, allowing for better detection of metastatic disease and differentiation between low-risk and high-risk patients.

The technique also offers higher sensitivity and spatial resolution compared to traditional gamma scintigraphy, which aids in detecting recurrent disease and enables accurate radiation dosimetry for personalized radioiodine therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of (124)I-PET in diagnosis and treatment of thyroid carcinoma. Lubberink, M., Abdul Fatah, S., Brans, B., et al.[2016]

Iodine-124 PET imaging is effective for visualizing iodine transport in about 80% of well-differentiated thyroid cancers, providing high-quality images that can help assess tumor characteristics.

This imaging technique may serve as a valuable tool to predict the success of iodine-131 therapy in thyroid cancer, potentially guiding personalized treatment strategies for various diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Role of Iodine-124-Positron Emission Tomography Imaging in the Management of Patients with Thyroid Cancer. Grewal, RK., Lubberink, M., Pentlow, KS., et al.[2016]

Iodine-124 (124I)-positron emission tomography (PET) was found to be a superior diagnostic tool compared to the traditional iodine-131 (131I) whole-body scan (WBS) in patients with advanced differentiated thyroid carcinoma, showing clearer and more extensive uptake in 11 out of 20 patients.

The 124I-PET results were able to predict findings on subsequent high-dose post-treatment 131I scans, indicating its potential for better clinical decision-making in managing advanced thyroid cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The diagnostic value of 124I-PET in patients with differentiated thyroid cancer. Phan, HT., Jager, PL., Paans, AM., et al.[2023]

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]

The study analyzed 5 procedures in 4 pediatric patients (ages 11-15) with differentiated thyroid carcinoma (DTC) and found that 124I-PET/CT dosimetry is safe, with only mild hypothyroid fatigue reported as a side effect.

The dosimetry results indicated high radiation doses to thyroid remnants (median 288 Gy/GBq) and lower doses to metastatic lymph nodes (median 6.5 Gy/GBq), suggesting that this imaging technique can effectively inform treatment decisions and clarify disease extent in young patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

124-iodine positron emission tomography/computed tomography dosimetry in pediatric patients with differentiated thyroid cancer. Freudenberg, LS., Jentzen, W., Marlowe, RJ., et al.[2016]

The study successfully modeled the production of 124I using Monte Carlo simulations and experimental data, achieving an impressive production efficiency of over 41% for natural Te targets.

The combination of simulation and experimental techniques allows for optimized production methods of 124I, which is crucial for improving the quality of PET imaging and targeted therapies in medical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficiency of 124I radioisotope production from natural and enriched tellurium dioxide using 124Te(p,xn)124I reaction. Bzowski, P., Borys, D., Gorczewski, K., et al.[2022]

Handling 124I can expose PET/CT workers to high skin doses, with initial measurements showing rates up to 100 mSv/min, particularly from beta radiation when using unshielded syringes.

After optimizing the dispensing procedure with improved shielding, the skin dose was reduced to below 0.2 mSv, demonstrating that effective radioprotection can significantly lower occupational exposure risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hard beta and gamma emissions of 124I. Impact on occupational dose in PET/CT. Kemerink, GJ., Franssen, R., Visser, MG., et al.[2015]

In a study involving 21 adults with goiter, 124I-PET/CT was found to detect significantly more thyroid nodules and 'hot spots' compared to the standard 99mTc-PT planar scintigraphy and SPECT, indicating its greater sensitivity for identifying benign thyroid conditions.

The 124I-PET/CT also identified more anatomical variations, such as lobus pyramidalis and retrosternal thyroid tissue, suggesting it may offer enhanced imaging capabilities for better characterization of thyroid anatomy and pathology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Low-activity 124I-PET/low-dose CT versus 99mTc-pertechnetate planar scintigraphy or 99mTc-pertechnetate single-photon emission computed tomography of the thyroid: a pilot comparison. Darr, AM., Opfermann, T., Niksch, T., et al.[2016]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Combined PET/CT with iodine-124 in diagnosis of spread metastatic thyroid carcinoma: a case report. [2020]

2. Italy pubmed.ncbi.nlm.nih.gov

The role of (124)I-PET in diagnosis and treatment of thyroid carcinoma. [2016]

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

The Role of Iodine-124-Positron Emission Tomography Imaging in the Management of Patients with Thyroid Cancer. [2016]

4. Germany pubmed.ncbi.nlm.nih.gov

The diagnostic value of 124I-PET in patients with differentiated thyroid cancer. [2023]

5. Italy pubmed.ncbi.nlm.nih.gov

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

6. Germany pubmed.ncbi.nlm.nih.gov

124-iodine positron emission tomography/computed tomography dosimetry in pediatric patients with differentiated thyroid cancer. [2016]

7. Germany pubmed.ncbi.nlm.nih.gov

Efficiency of 124I radioisotope production from natural and enriched tellurium dioxide using 124Te(p,xn)124I reaction. [2022]

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

Hard beta and gamma emissions of 124I. Impact on occupational dose in PET/CT. [2015]

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

Low-activity 124I-PET/low-dose CT versus 99mTc-pertechnetate planar scintigraphy or 99mTc-pertechnetate single-photon emission computed tomography of the thyroid: a pilot comparison. [2016]