I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
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 of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination of
| Condition(s) | Thyroid Cancer, RAI-Refractory Thyroid Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 of extent (volume and pattern) of remnant tissue in post total thyroidectomy setting and distinction of nodal metastases vs remnant tissue for determination of indication for RAI ablation, 2) Evaluation of response to RAI remnant ablation, 3) Evaluation for suspected occult recurrent/metastatic disease, 4) Evaluation of extent of disease in patients with known metastatic disease and 5) Evaluation of RAI avidity of recurrent/metastatic thyroid cancer and response to treatment with thyroid kinase inhibitors (TKI). Patients who underwent total thyroidectomy for thyroid cancers are studied. Patients who are newly diagnosed, as well as |
| Who can participate | 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 ≥ |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Miami Cancer Research Center, Inc. |
| Locations | North Miami, Florida, United States |
| Start date | 2022-02-01 |
| NCT ID | NCT06443866 |
| Official listing | https://clinicaltrials.gov/study/NCT06443866 |