I-124 PET/CT for Thyroid Cancer

Overseen By Maya Aslam

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Thomas Hope

Disqualifiers: Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 1 day

58 Participants Needed

Trial Summary

What is the purpose of this trial?

Persons diagnosed with thyroid cancer are often treated initially with a thyroidectomy, which is followed by ablation using Iodine-131, a therapy which has been shown to be effective and safe. Imaging of metastatic thyroid cancer has been performed with whole body I-131 and Iodine 123 (I-123) imaging for many decades and use I-123 for staging studies. Iodine 124 (I-124) is a radioisotope of iodine which emits a positron and is imaged using PET (positron emission tomography). 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, usual care I-123 and I-131 images.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the treatment Iodine-124 for thyroid cancer?

Iodine-124, used in PET/CT scans, helps doctors better understand the spread and severity of thyroid cancer, which can improve treatment planning. It provides clearer images than older methods, making it easier to detect cancer and tailor treatments to individual patients. ^{1 2 3 4 5}

Is I-124 PET/CT safe for use in humans?

I-124 PET/CT is generally considered safe for use in humans, as it is used to improve diagnosis and treatment planning for thyroid cancer by providing detailed imaging. However, more studies are needed to optimize its use and ensure it avoids toxicity to normal organs. ^{1 3 4 6 7}

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

Iodine-124 is unique because it is used in PET/CT imaging to provide detailed 3D images that help in accurately staging thyroid cancer and planning personalized treatment. Unlike traditional methods, it allows for precise measurement of iodine uptake, which is crucial for tailoring radioiodine therapy to individual patients. ^{1 3 4 5 8}

Research Team

Thomas Hope, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

This trial is for individuals who have been diagnosed with thyroid cancer and are undergoing standard care, which typically includes surgery followed by Iodine-131 ablation. Participants should not be currently receiving other experimental treatments.

Inclusion Criteria

Ability to understand a written informed consent document and the willingness to sign it

My thyroid cancer is confirmed and shows signs of spreading.

My thyroglobulin levels are high after having my thyroid removed.

Exclusion Criteria

Known pregnancy per institutional policy

Unlikely to comply with study procedures, restrictions, and requirements as judged by the Investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an oral dose of I-124 followed by a PET/CT scan to detect metastatic thyroid cancer

1 day

1 visit (in-person)

Follow-up

Participants are monitored for adverse events after the PET/CT scan

3-5 days

Follow-up by phone

Treatment Details

Interventions

• Iodine-124

Trial Overview The study is testing the effectiveness of a new imaging technique using Iodine-124 (I-124) and PET/CT scans to detect metastatic thyroid cancer, compared to traditional imaging with Iodine-123 (I-123) and Iodine-131 (I-131).

Participant Groups

Group I: Intervention: I-124 PET/CT Experimental Treatment 2 Interventions

All participants will be administered an oral dose of 60 to 85 megabecquerel (MBq) +/- 10% for I-124 (capsule) prior to the Positron Emission Tomography (PET) imaging. Scan coverage will extend from the vertex to the mid-thighs and in certain circumstances, coverage may be extended to the toes. Imaging will be acquired 20-28 hours after I-124 administered. Participants will be followed up for any adverse events for up to 5 days after the scan has been completed.

Who Is Running the Clinical Trial?

Thomas Hope

Lead Sponsor

Trials

11

Recruited

1,800+

Findings from Research

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]

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]

I-124 PET imaging offers improved sensitivity and spatial resolution for diagnosing and treating differentiated thyroid cancer compared to traditional gamma scintigraphy, potentially enhancing the detection of recurrent or metastatic disease.

There is a need for more prospective studies to establish optimal dosimetry protocols for I-124, which will help tailor treatment plans to maximize tumor absorption while minimizing toxicity to healthy organs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I-124 Imaging and Dosimetry. Kuker, R., Sztejnberg, M., Gulec, S.[2022]

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]

References

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

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

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

Positron emission tomography in thyroid cancer management. [2019]

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. Italy pubmed.ncbi.nlm.nih.gov

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

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

Imaging with (124)I in differentiated thyroid carcinoma: is PET/MRI superior to PET/CT? [2018]

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

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

7. Turkey pubmed.ncbi.nlm.nih.gov

I-124 Imaging and Dosimetry. [2022]

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

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