I-124 PET/CT Imaging and Dosimetry for RAI-Naïve or Refractory Thyroid Cancer
NCT ID: NCT06443866
Last Updated: 2024-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2022-02-01
2029-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Thyroid Cancer patients, RAI-naive or refractory
Disease status detection
RAI dose determination
Theranostic dosimetry
Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer
I-124 PET/CT imaging
Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer
Interventions
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Disease status detection
RAI dose determination
Theranostic dosimetry
Theranostic dosimetric evaluation for optimization of RAI therapy of thyroid cancer
I-124 PET/CT imaging
Theranostic dosimetry for optimization of RAI therapy for Thyroid Cancer
Eligibility Criteria
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Inclusion Criteria
* 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
* Age \< 18
* Inability or unwillingness to give a written consent
* Life expectancy \< 3 months
* ECOG performance status ≥ 3
* Pregnant and nursing women.
18 Years
ALL
No
Sponsors
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Miami Cancer Research Center, Inc.
OTHER
Responsible Party
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Principal Investigators
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Seza Gulec, MD
Role: PRINCIPAL_INVESTIGATOR
CEO, MCRC
Locations
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Miami Cancer Research Center
North Miami, Florida, United States
Countries
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Central Contacts
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Keila Rios
Role: CONTACT
Facility Contacts
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Other Identifiers
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MBK funding
Identifier Type: OTHER
Identifier Source: secondary_id
MTOCP03
Identifier Type: -
Identifier Source: org_study_id
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