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

Thyroid Cancer Clinical Trial

Official title:

CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443866
• Other study ID #: MTOCP03
• Secondary ID: MBK funding
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: December 2029

Study information

• Verified date: May 2024
• Source: Miami Cancer Research Center, Inc.
• Contact: Seza Gulec, MD
• Phone: 786-693-0821
• Email: sezagulec[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2029
• Est. primary completion date: January 31, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Diagnostic Test:
• Disease status detection
RAI dose determination
• Theranostic dosimetry
Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer

Drug:
• I-124 PET/CT imaging
Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer

Locations

Country	Name	City	State
United States	Miami Cancer Research Center	North Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Miami Cancer Research Center, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification and characterization of RAI uptake pattern and kinetics	Measurements: Administered activity; Cumulated activity; Standard uptake value; Calculations: 1. Radiation absorbed dose to the target; Correlations to be reported: Administered activity vs absorbed dose; Absorbed dose vs response; SUV at 48h vs response	5 years