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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to predict the effectiveness of radioactive iodine treatment for metastatic thyroid cancer. It uses a form of iodine, 124-I, to measure the radiation each cancer spot will receive, aiding doctors in determining the best treatment plan. The goal is to avoid unnecessary radiation for patients unlikely to benefit and to customize the treatment dose for those who will. The primary treatment under study is 131-I, another form of radioactive iodine. The trial seeks adults with thyroid cancer who have had their thyroid removed and show iodine-absorbing cancer spots, confirmed by specific scans within the last six months. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative approach.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that radioactive iodine, specifically 131-I, has treated thyroid cancer that has spread for over 50 years. Patients usually tolerate it well, though high doses can cause side effects like burns to the eyes and skin. Studies indicate that radiation exposure to people around patients receiving 131-I remains generally low and within safe limits.

Regarding 124-I, research has found it very safe for detecting thyroid cancer. It does not cause major side effects to the thyroid gland, the main organ it affects. This iodine type helps predict the effectiveness of 131-I treatment, potentially reducing unnecessary radiation exposure for some patients.

Both types of iodine have undergone thorough study. If concerns arise, discussing them with a healthcare provider before joining a trial is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Most treatments for thyroid cancer involve surgery, chemotherapy, or the use of radioactive iodine (RAI) like 131-I. What makes 131-I iodine unique is its targeted approach, which allows it to specifically attack thyroid cancer cells with minimal impact on the rest of the body. Researchers are particularly excited about its potential for precise dosimetry, which means they can tailor the amount of radiation each patient receives for optimal effectiveness. This precision not only aims to improve treatment outcomes but also reduces the risk of side effects, making it a promising option for those battling thyroid cancer.

What evidence suggests that this trial's treatments could be effective for thyroid cancer?

This trial will evaluate the use of 131-I and 124-I for thyroid cancer. Studies have shown that 131-I is highly effective for treating thyroid cancer, especially when combined with surgery, with up to 90% of patients achieving remission. However, some patients may experience a recurrence after treatment. Meanwhile, 124-I proves very useful in detecting cancer spread, particularly with newer, more precise PET scanners. Research indicates that 124-I can identify patients who might not respond well to 131-I, potentially sparing them unnecessary radiation. This personalized approach aims to improve treatment success by tailoring radiation doses to each patient's needs. ^{2 3 6 7 8}

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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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.

jnm.snmjournals.org

jnm.snmjournals.org/content/57/5/701

124I PET/CT to Predict the Outcome of Blind 131I Treatment in ...

Implementation of 124I PET in this setting would have led to 47% (8/17) less futile 131I treatments, but 29% of patients (5/17) would have been ...

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.

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, ...

5.

miamicancerresearch.org

miamicancerresearch.org/images/Publications/Thyroid-MTOCP1-124I_PET-CT_in_Patients_with_Differentiated_Thyroid_Cancer.pdf

124I PET/CT in Patients with Differentiated Thyroid Cancer

The objectives of this study were to determine the imaging characteristics and clinical feasibility of 124I positron emission tomography/computed tomography ( ...

6.

hpschapters.org

hpschapters.org/northcarolina/NSDS/124IPDF.pdf

Nuclide Safety Data Sheet Iodine-124

... 124I ingested [Thyroid]. 1.69E-7 Sv/Bq (6.25E2 mrem/uCi) of 124I inhaled [Thyroid]. Critical Organ: Thyroid Gland. Intake Routes: Ingestion, inhalation ...

7.

richtlijnendatabase.nl

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

124I PET/CT in Thyroid Cancer

124I PET (/CT) may be able to detect recurrent or residual disease in DTC with a higher sensitivity than the conventional (diagnostic) 131I scans because of the ...

8.

clinicaltrials.ucsf.edu

clinicaltrials.ucsf.edu/trial/NCT06961084

I-124 PET/CT for the Diagnosis of Thyroid Cancer

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, ...