Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06443866 | RECRUITING | Thyroid Cancer

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

Condition or disease

Thyroid Cancer

RAI-Refractory Thyroid Cancer

Intervention/treatment

Disease status detection

Theranostic dosimetry

I-124 PET/CT imaging

Study Type : OBSERVATIONAL
Estimated Enrollment : 50 participants
Official Title : CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
Actual Study Start Date : 2022-02-01
Estimated Primary Completion Date : 2029-01-31
Estimated Study Completion Date : 2029-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
    • I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer

    Location Details

    NCT06443866

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, Florida

    Miami Cancer Research Center

    North Miami, Florida, United States, 33181