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

62 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to detect thyroid cancer spread using Iodine-124 (I-124) with PET/CT scans. Researchers compare the effectiveness of I-124 in finding cancer to the usual methods, which use I-123 and I-131. The trial seeks individuals diagnosed with thyroid cancer who have had their thyroid removed and show signs of potential cancer spread, such as noticeable spots on scans or specific blood test results. Participants will receive a dose of I-124 and undergo a scan to assess its effectiveness in detecting cancer. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group.

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 prior data suggests that I-124 PET/CT is safe for detecting metastatic thyroid cancer?

Research has shown that Iodine-124 (I-124) is generally safe and well-tolerated for thyroid cancer imaging. In studies, patients underwent a single I-124 PET/CT scan and were observed for a few days afterward. They did not report any significant negative side effects during this period.

Iodine-124 is a special type of iodine used in PET scans to detect thyroid cancer. It has proven more effective at identifying cancerous areas than other iodine types used in similar scans. This capability may help doctors identify cancer more accurately, aiding in treatment planning.

Overall, the research suggests that I-124 is safe for imaging, with no major safety concerns reported in the reviewed studies. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about using I-124 PET/CT for thyroid cancer because it offers a more precise imaging technique compared to traditional options. Unlike standard scans, which might not detect small or residual cancer areas, I-124 PET/CT uses a radioactive iodine isotope that is absorbed by thyroid cancer cells, providing clearer and more detailed images. This could potentially lead to better-targeted treatments and improved monitoring of treatment effectiveness, which are significant steps forward in managing thyroid cancer.

What evidence suggests that I-124 PET/CT is effective for detecting metastatic thyroid cancer?

Research has shown that Iodine-124 (I-124) PET/CT, which participants in this trial will receive, is a promising method for detecting thyroid cancer. Studies indicate that it can identify cancerous areas, even those that other imaging methods might miss. I-124 PET/CT is highly sensitive, capable of detecting small or hard-to-find cancer spots. This imaging method may be particularly useful for identifying thyroid cancer that has spread. Overall, I-124 PET/CT can help doctors determine the extent of thyroid cancer more accurately. ^{1 2 5 6 7}

Who Is on the Research Team?

Thomas Hope, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Published Research Related to This Trial

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]

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]

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/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]

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]

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 has recently been applied for staging of differentiated thyroid cancer, as reported in a few case reports and small series, with promising results [ ...

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.

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.

5.

thyroid.org

thyroid.org/patient-thyroid-information/ct-for-patients/october-2017/vol-10-issue-10-p-6-7/

Is I-124 PET/CT useful in identifying thyroid cancer ...

The authors concluded that I-124 PET/CT is a sensitive technique to identify thyroid cancer lesions that may be able to respond to treatment by radioactive ...

6.

jnm.snmjournals.org

jnm.snmjournals.org/content/64/supplement_1/P1458

Prospective comparison of F-18-TFB and I-124 PET/CT in ...

In thyroid cancer, F-18-TFB-PET/CT may be an alternative to iodine imaging to evaluate the extent of disease and eligibility to radioiodine treatment. We report ...

7.

mirt.tsnmjournals.org

mirt.tsnmjournals.org/articles/i-124-imaging-and-dosimetry/2017.26.suppl.07

I-124 Imaging and Dosimetry

I-124 identified 22.5% more foci of RAI avid lesions as compared to the planar I-131 post-treatment scans. In addition, the I-124 images provided discriminating ...