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临床试验/NCT06443866
NCT06443866招募中不适用

CLINICAL UTILITY AND FEASIBILITY OF I-124 PET/CT IMAGING AND DOSIMETRY IN PATIENTS WITH THYROID CANCER

Miami Cancer Research Center, Inc.1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
50
试验地点
1
主要终点
Identification and characterization of RAI uptake pattern and kinetics

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Thyroid Cancer patients, RAI-naive or refractory

干预措施: Disease status detection (Diagnostic Test)

Thyroid Cancer patients, RAI-naive or refractory

干预措施: Theranostic dosimetry (Diagnostic Test)

Thyroid Cancer patients, RAI-naive or refractory

干预措施: I-124 PET/CT imaging (Drug)

结局指标

主要结局

Identification and characterization of RAI uptake pattern and kinetics

时间窗: 5 years

Measurements: 1. Administered activity 2. Cumulated activity 3. Standard uptake value Calculations: 1. Radiation absorbed dose to the target Correlations to be reported: 1. Administered activity vs absorbed dose 2. Absorbed dose vs response 3. SUV at 48h vs response

次要结局

未报告次要终点

研究者

发起方
Miami Cancer Research Center, Inc.
申办方类型
Other
责任方
Sponsor

研究点 (1)

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