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

Recruiting

• Conditions: RAI-Refractory Thyroid Cancer; Thyroid Cancer
• Interventions: Diagnostic Test: Disease status detection; Diagnostic Test: Theranostic dosimetry; Drug: I-124 PET/CT imaging

• Registration Number: NCT06443866
• Lead Sponsor: Miami Cancer Research Center, Inc.

Brief 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-01
• Status Verified: 2024-05
• Study First Submitted: 2024-05-23
• Study First Submitted QC: 2024-05-29
• Last Update Submitted: 2024-05-29
• Study First Posted: 2024-06-05
• Last Update Posted: 2024-06-05
• Primary Completion: 2029-01-31
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Thyroid Cancer patients, RAI-naive or refractory	Disease status detection	-
Thyroid Cancer patients, RAI-naive or refractory	Theranostic dosimetry	-
Thyroid Cancer patients, RAI-naive or refractory	I-124 PET/CT imaging	-

Primary Outcome Measures

Name	Time	Method
Identification and characterization of RAI uptake pattern and kinetics	5 years	Measurements: 1. Administered activity; 2. Cumulated activity; 3. Standard uptake value; Calculations: 1. Radiation absorbed dose to the target; Correlations to be reported: 1. Administered activity vs absorbed dose; 2. Absorbed dose vs response; 3. SUV at 48h vs response

Trial Locations

Locations (1)

Miami Cancer Research Center; 🇺🇸 North Miami, Florida, United States