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

Purpose

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.

Conditions

  • Thyroid Cancer
  • RAI-Refractory Thyroid Cancer

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Thyroid Cancer patients, RAI-naive or refractory
  • Diagnostic Test: Disease status detection
    RAI dose determination
  • Diagnostic Test: 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

Recruiting Locations

Miami Cancer Research Center
North Miami, Florida 33181
Contact:
Seza Gulec, MD
786-693-0821
sezagulec@gmail.com

More Details

Status
Recruiting
Sponsor
Miami Cancer Research Center, Inc.

Study Contact

Seza Gulec, MD
786-693-0821
sezagulec@gmail.com