I-124 PET/CT Imaging for Thyroid Cancer

Overseen By Keila Rios

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Miami Cancer Research Center, Inc.

Must be taking: Thyroid kinase inhibitors

Disqualifiers: Metastatic cancers, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a special imaging technique, I-124 PET/CT, for individuals with thyroid cancer. It helps doctors assess residual cancer post-surgery, detect cancer spread, and evaluate treatment effectiveness. The trial includes participants who have had their thyroid removed, suspect cancer recurrence, or are on specific cancer medications. As a Phase 2 trial, this research measures the imaging's effectiveness in an initial, smaller group, allowing participants to contribute to significant advancements in thyroid cancer care.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that patients on thyroid kinase inhibitors (TKI) are eligible for evaluation, so you might be able to continue those treatments.

What prior data suggests that I-124 PET/CT imaging is safe for thyroid cancer patients?

Research has shown that I-124 PET/CT imaging is generally easy for patients to handle. Studies have found that I-124, a type of medicine used in PET scans, is safe and helps doctors obtain clear and detailed images to detect and assess thyroid cancer. There are no major reports of serious side effects from its use, indicating that the procedure carries little risk of negative effects. The imaging method is non-invasive, as it does not involve surgery or entering the body, further enhancing its safety and reliability for those being screened for thyroid cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using I-124 PET/CT imaging for thyroid cancer because it offers a new way to visualize and understand the disease. Unlike traditional imaging methods, this technique uses a radioactive tracer, I-124, which helps in precisely mapping the spread and activity of cancer cells in real-time. This advanced imaging can potentially lead to more accurate dosimetry, meaning it can help tailor radiation doses specifically to the patient's needs. By improving targeting and treatment planning, I-124 PET/CT imaging could enhance outcomes for patients who are either new to or unresponsive to standard radioactive iodine therapies.

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

Research has shown that I-124 PET/CT imaging, studied in this trial, holds promise for thyroid cancer patients, particularly in detecting cancer spread. Studies have found that this imaging technique excels at identifying cancerous tissues, allowing for more accurate detection. It enables doctors to assess the extent of disease spread and evaluate the effectiveness of treatments like radioactive iodine therapy. This method allows doctors to plan treatments more effectively for individuals, especially those who have had their thyroid gland removed. Overall, I-124 PET/CT imaging provides more precise care for thyroid cancer patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Seza Gulec, MD

Principal Investigator

CEO, MCRC

Are You a Good Fit for This Trial?

Inclusion Criteria

My thyroid cancer is resistant to radioactive iodine and I am being considered for targeted therapy.

I am 18 years old or older.

I am willing and able to sign a consent form.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging and Dosimetry Evaluation

Evaluation of I-124 PET/CT imaging and dosimetry to assess remnant tissue, nodal metastases, and RAI avidity in thyroid cancer patients

Varies per patient

Treatment Evaluation

Evaluation of response to RAI remnant ablation and TKI treatment in patients with thyroid cancer

Varies per patient

Follow-up

Participants are monitored for safety and effectiveness after imaging and treatment evaluations

5 years

What Are the Treatments Tested in This Trial?

Interventions

• I-124 PET/CT Imaging

How Is the Trial Designed?

Group I: Thyroid Cancer patients, RAI-naive or refractory Experimental Treatment 3 Interventions

Who Is Running the Clinical Trial?

Miami Cancer Research Center, Inc.

Lead Sponsor

Trials

1

Recruited

50+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06443866

I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or ...

The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer including 1) Evaluation ...

2.

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- ...

3.

jnm.snmjournals.org

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

Digital high sensitivity I-124 PET/CT improves the detectability ...

A significantly higher detection sensitivity for I-124 by digital PET/CT was observed in clinical and phantom settings.

4.

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 ...

In this study, a systematic review of the literature and pooled analysis of published data was performed, to determine how effective I-124 PET/CT is in ...

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.

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, ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5283715/

I-124 Imaging and Dosimetry - PMC

I-124 is a PET radiopharmaceutical with a 4.2-day half life. It offers superior imaging characteristics with enhanced spatial resolution and image sensitivity.

8.

trialx.com

trialx.com/clinical-trials/listings/292380/i-124-petct-imaging-and-dosimetry-for-rai-naive-or-refractory-thyroid-cancer/

I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or ...

Overview. The objective of this study is to demonstrate the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid ...

9.

jnm.snmjournals.org

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

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

Results: Two patients had metastatic papillary and three patients had poorly differentiated thyroid cancer. Patients with poorly differentiated cancer were ...