Clinical Trial · NCT06443866

I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer

Overview

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 those who have known or suspected to have recurrent or metastatic disease are eligible. Patients receiving TKI treatment are eligible for evaluation prior to and after the treatment. The patients who are considered for TKI/MAPK treatments undergo pre and post treatment with clinically determined oncoprotein/TKR therapeutic agent(s), including multi-TKI, selective BRAF, MEK, PI3K or ERK inhibitors or combination treatments.

Sponsor

Unknown Organization

Contacts

Keila Rios (CONTACT)

786-487-3230

Seza Gulec, MD (PRINCIPAL_INVESTIGATOR)

Seza Gulec, MD (CONTACT)

sezagulec@gmail.com

786-693-0821

ClinicalTrials.gov

NCT06443866

Drug / Compound

iodide

Isotope(s):

Target(s):

No Explicit Target

Ligand Class: Small Molecules

Eligibility

Inclusion

Inclusion Criteria
Life expectancy \< 3 months
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
ECOG performance status ≤ 2Exclusion Criteria
ECOG performance status ≥ 3
Pregnant and nursing women.
Pretreatment and post-treatment evaluation of patients with thyroid cancer deemed RAI-indifferent/refractory who are considered for TKI
Patients with known or suspected recurrent/metastatic thyroid cancer, identified by ultrasound (US), CT/MR/FDG-PET\|CT or elevated thyroglobulin (Tg).
Life expectancy \> 3 months
Ability and willingness to give a written consent
Inability or unwillingness to give a written consent
Cancers metastatic to thyroid

Exclusion

Exclusion criteria not yet provided.