RecruitingNCT06443866

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

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


Sponsor

Miami Cancer Research Center, Inc.

Enrollment

50 participants

Start Date

Feb 1, 2022

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria7

  • 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 Criteria6

  • 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.

Interventions

DIAGNOSTIC_TESTDisease status detection

RAI dose determination

DIAGNOSTIC_TESTTheranostic dosimetry

Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer

DRUGI-124 PET/CT imaging

Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer


Locations(1)

Miami Cancer Research Center

North Miami, Florida, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06443866


Related Trials