Iodine-124 Imaging for Thyroid Cancer

Recruiting at 1 trial location

Overseen By Steven Larson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Age less than 18, Pregnancy

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

Compensation: Varies

Number of Visits: 4

Duration: Variable

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assess how well thyroid cancer absorbs iodine, using a PET scan with iodine-124, a radioactive iodine form. It aims to help doctors determine the best treatment path, especially when standard radioactive iodine therapy may not be effective. The trial includes several PET/CT scans to obtain detailed images of the cancer. Adults with thyroid cancer who have had their thyroid removed and show signs of cancer spread are suitable candidates for this study. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.

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 prior data suggests that this diagnostic imaging test is safe?

Research shows that iodine-124 PET scans are usually well-tolerated by patients. Studies on using iodine-124 for thyroid cancer imaging have not found major safety issues. Most participants in these studies did not experience serious side effects.

Some might experience mild side effects, such as discomfort or a slight reaction at the injection site. However, these are uncommon and can usually be managed easily. Only a tiny amount of iodine-124 is used for imaging, which helps ensure safety.

This study is in an early phase, focusing on understanding how the treatment works and assessing its safety. This phase is crucial to ensure the treatment's safety for more people in future studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for thyroid cancer, which often involve surgery and radioactive iodine therapy with Iodine-131, Iodine-124 PET/CT imaging offers a unique approach by providing precise lesion dosimetry. This means it can better measure how tumors take up and clear radioactive iodine, potentially leading to more tailored and effective treatment plans. Researchers are excited because this method could improve the accuracy of treatment dosing, minimize unnecessary radiation exposure, and enhance the overall effectiveness of thyroid cancer management.

What evidence suggests that this imaging method is effective for thyroid cancer?

This trial will use Iodine-124 PET scans to evaluate their effectiveness in detecting thyroid cancer. Studies have shown that Iodine-124 PET scans can detect thyroid cancer more effectively than traditional methods. Research indicates that this technique may identify returning or remaining cancer with greater accuracy. In some cases, it is particularly useful for finding areas of abnormal tissue that absorb little radioiodine, providing clearer images of cancer spread. Additionally, the high sensitivity of Iodine-124 PET/CT scans improves the detection of cancer that has spread to other parts of the body. ^{1 6 7 8 9}

Who Is on the Research Team?

Ravinder Grewal, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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

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

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

My thyroid cancer diagnosis is confirmed by a pathology report.

Exclusion Criteria

Patients who are pregnant

I am under 18 years old.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Iodine-124
• PET/CT Scan

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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 (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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2292795/

The diagnostic value of 124I-PET in patients with differentiated ... Iodine-124 PET may be able to detect recurrent or residual disease in differentiated thyroid carcinoma (DTC) with a higher sensitivity than the conventional ( ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06961084

Comparison of I-124 PET/CT for the Diagnosis of Thyroid ... All participants will have a single PET/CT scan after administration of I-124 and will be followed for up to 3-5 days by phone for evaluation of adverse events.

3. ejnmmiphys.springeropen.com ejnmmiphys.springeropen.com/articles/10.1186/s40658-021-00361-y

Comparing lesion detection efficacy and image quality across ... In recurrent differentiated thyroid cancer patients, detectability in 124I PET is limited for lesions with low radioiodine uptake.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35119623/

I-124 PET/CT image-based dosimetry in patients with ... The objective of this study is to evaluate the lesion absorbed dose (AD), biological effective dose (BED), and equivalent uniform dose (EUD) to clinical- ...

5. jnm.snmjournals.org jnm.snmjournals.org/content/61/supplement_1/255

Digital high sensitivity I-124 PET/CT improves the detectability ... Digital high sensitivity I-124 PET/CT improves the detectability of thyroid cancer metastases | Journal of Nuclear Medicine.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06961084

Comparison of I-124 PET/CT for the Diagnosis of Thyroid ... This is a single arm prospective trial that evaluates the ability of Iodine-124 (I-124) to detect metastatic thyroid cancer compared to non-interventional, ...

7. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT06961084

I-124 PET/CT for the Diagnosis of Thyroid Cancer Inter-reader variability for I-124 PET and I-123 SPECT. Safety of I-124 PET. Participant level detection rate for I-124 in the overall population.

8. richtlijnendatabase.nl richtlijnendatabase.nl/gerelateerde_documenten/f/17259/124I%20PETCT%20in%20Thyroid%20Cancer.pdf

124I PET/CT in Thyroid Cancer Total thyroidectomy with or without lymph node dissection is the initial therapy and is followed by radioactive iodine therapy to remove thyroid remnants and ...

9. jnm.snmjournals.org jnm.snmjournals.org/content/49/6/1017

Optimized 124I PET Dosimetry Protocol for Radioiodine ... The adapted 24-96-h approach appears to be the optimal 124 I protocol and is a reliable simplification of the 5-point protocol.