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

Miami Cancer Research Center, Inc.

Status: Enrolling

Conditions: RAI-Refractory Thyroid Cancer; Thyroid Cancer

Treatments: Diagnostic Test: Theranostic dosimetry; Diagnostic Test: Disease status detection; Drug: I-124 PET/CT imaging

Study type: Observational

Funder types: Other

Identifiers

NCT06443866

MTOCP03

MBK funding (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

50 participants in 1 patient group

Thyroid Cancer patients, RAI-naive or refractory

Treatment:

Drug: I-124 PET/CT imaging

Diagnostic Test: Disease status detection

Diagnostic Test: Theranostic dosimetry