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

Part of paid clinical trials in North Miami, Florida.

Sponsor
Miami Cancer Research Center, Inc.
Study ID
NCT06443866
Status
Recruiting
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Conditions

  • RAI-Refractory Thyroid Cancer
  • Thyroid Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Disease status detection — DIAGNOSTIC_TEST
    RAI dose determination
  • Theranostic dosimetry — DIAGNOSTIC_TEST
    Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer
  • I-124 PET/CT imaging — DRUG
    Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer

Study Details

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.

Key Dates

Start date
Feb 1, 2022
Status verified
May 2024
Primary completion
Jan 31, 2029
Completion
Dec 31, 2029

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Thyroid Cancer patients, RAI-naive or refractory

Primary Outcome Measure

Identification and characterization of RAI uptake pattern and kinetics [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Miami Cancer Research CenterNorth MiamiFlorida33181
Seza Gulec, MD
[email protected]
786-693-0821

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By research site
Miami Cancer Research Center· North Miami, FL

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