I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Disease status detection, Theranostic dosimetry, I-124 PET/CT imaging.
- Who it may be relevant to
- Registry conditions: Thyroid Cancer, RAI-Refractory Thyroid Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER
Overview
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.
Interventions
- 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
Primary outcome measures
- Identification and characterization of RAI uptake pattern and kinetics [Time frame: 5 years]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
United States · 1 center
- Miami Cancer Research Center — North Miami
Identifiers
NCT: NCT06443866 · MTOCP03 · MBK funding