Using I-124 PET/CT imaging for thyroid cancer evaluation
CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
Miami Cancer Research Center, Inc. · NCT06443866
This study is testing a new type of imaging to see if it can help doctors better understand and treat thyroid cancer in both newly diagnosed patients and those with ongoing concerns.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Miami Cancer Research Center, Inc. (other) |
| Locations | 1 site (North Miami, Florida) |
| Trial ID | NCT06443866 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the clinical utility of I-124 PET/CT imaging and dosimetry in patients with thyroid cancer. It focuses on evaluating the extent of remnant tissue after total thyroidectomy, distinguishing between nodal metastases and remnant tissue, and assessing responses to RAI ablation. Additionally, it will evaluate suspected recurrent or metastatic disease and the RAI avidity of recurrent thyroid cancer in patients undergoing treatment with thyroid kinase inhibitors. The study includes both newly diagnosed patients and those with known or suspected disease.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who have undergone total thyroidectomy for thyroid cancer and may have residual or metastatic disease.
Not a fit: Patients with cancers metastatic to the thyroid or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of thyroid cancer evaluations and improve treatment decisions for patients.
How similar studies have performed: While the use of PET imaging in cancer evaluation is established, the specific application of I-124 PET/CT for thyroid cancer is less common and may represent a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * Post-total thyroidectomy patients with diagnosis of thyroid cancer, any histology, subtype, any ATA risk category, for evaluation for residual disease, cervical or remote metastatic disease * Patients with known or suspected recurrent/metastatic thyroid cancer, identified by ultrasound (US), CT/MR/FDG-PET\|CT or elevated thyroglobulin (Tg). * Pretreatment and post-treatment evaluation of patients with thyroid cancer deemed RAI-indifferent/refractory who are considered for TKI * Age ≥ 18 * Ability and willingness to give a written consent * Life expectancy \> 3 months * ECOG performance status ≤ 2 Exclusion Criteria * Cancers metastatic to thyroid * Age \< 18 * Inability or unwillingness to give a written consent * Life expectancy \< 3 months * ECOG performance status ≥ 3 * Pregnant and nursing women.
Where this trial is running
North Miami, Florida
- Miami Cancer Research Center — North Miami, Florida, United States (RECRUITING)
Study contacts
- Principal investigator: Seza Gulec, MD — CEO, MCRC
- Study coordinator: Seza Gulec, MD
- Email: sezagulec@gmail.com
- Phone: 786-693-0821
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Thyroid Cancer, RAI-Refractory Thyroid Cancer, Redifferentiation Therapy