Personalized therapy of metastatic thyroid cancer: biological characterization and optimization with 124I PET dosimetry
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Evaluation of complete response (CR) rate on soft tissue metastases after a maximum of two radioiodine administrations optimized with personalized pre-treatment dosimetry based on 124I-PET/CT. The response will be considered 6 months [1] after the last optimized administration, as a combination of evaluations (RECIST, 124I-PET/CT, 18F-FDG, and thyroglobulin).
研究概览
简要总结
-investigate if dosimetry-based 131I administration may increase efficacy as compared to that obtained with fixed activity, with an acceptable toxicity in DTC patients with soft tissue and skeletal metastasis: -study if the mutational status, the gene expression and the variations of miRNA profiles before and after therapy of DTCs may be related to lesions’ refractoriness, even to personalized, 131I therapy
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histo-pathological diagnosis of DTC
- •At least one documented non surgically-curable soft-tissue metastasis previously untreated
- •ECOG performance status = 0 - 1
- •Age ≥ 18 years old
- •Life expectancy > 6 months
- •Females of childbearing age must have negative serum pregnancy test prior to registration and agree to use birth control throughout the study and for 6 months after completion of therapy
- •Preserved hematologic and renal function (hemoglobin > 10 g/dL; WBC > 3500/uL; neutrophilis > 50%; PLT > 100000/uL; albumin ≥ 2.5 g/dL; creatinine ≤ 2 mg/dL)
- •Signed informed consent
排除标准
- •All lesions surgically resectable
- •Assumption of any myelotoxic drugs
- •Previous or concomitant assumption of Amiodarone
- •Any other oncologic disease that required systemic treatment in the last 5 years. Cases who received previous loco-regional therapy on non-target lesions can be included (for example radiotherapy or surgery)
- •Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives prior to the study drug.
- •Hypersensitivity: history of allergic reactions or hypersensitivity to the active substance, to any of the excipients, to any of the components of the radiolabelled radiopharmaceutical.
- •Minimal lymph neck nodal disease (diameter < 1 cm, up to 2 nodes)
- •Patient with skeletal metastases only
- •Only lung uniformly diffuse miliary micro-metastases without other measurable nodules criteria
- •Ongoing pregnancy (enrollment could be considered after delivery)
- •Breast-feeding (enrollment could be considered after suspension)
- •Refusal of male and female patients to use an effective contraception method during the study and for 6 months after completion of protocol therapy
- •Impossibility to undergo follow-up procedures
- •Presence of medical, psychiatric or surgical condition, not adequately controlled by treatment, which would likely affect subjects’ ability to complete the protocol
研究组 & 干预措施
-
Participants receiving -
干预措施: - (Drug)
结局指标
主要结局
Evaluation of complete response (CR) rate on soft tissue metastases after a maximum of two radioiodine administrations optimized with personalized pre-treatment dosimetry based on 124I-PET/CT. The response will be considered 6 months [1] after the last optimized administration, as a combination of evaluations (RECIST, 124I-PET/CT, 18F-FDG, and thyroglobulin).
Evaluation of complete response (CR) rate on soft tissue metastases after a maximum of two radioiodine administrations optimized with personalized pre-treatment dosimetry based on 124I-PET/CT. The response will be considered 6 months [1] after the last optimized administration, as a combination of evaluations (RECIST, 124I-PET/CT, 18F-FDG, and thyroglobulin).
次要结局
- Assessment of acute toxicity rate and severity
- Assessment of the association among pre-treatment glucose metabolism, 124I uptake and therapy response
- Assessment of the association among genetic mutations on cancer tissue, pre- and post-treatment miRNA expression, pre- and post-treatment glucose metabolism, iodine uptake, and 131I therapy response
研究者
S.C: Medicina Nucleare
Scientific
Fondazione IRCCS Istituto Nazionale Dei Tumori