CTIS2022-500477-14-00进行中（未招募）1 期
Digoxin for the Reinduction or Radioiodine Uptake in Metastatic or Locally Advanced Non-medullary Thyroid Carcinoma. - 113327
Stichting Radboud University Medical Center0 个研究点目标入组 10 人开始时间: 2022年6月9日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
研究概览
简要总结
Summary of Results
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Being diagnosed with NMTC., Being aged =18 years., Having undergone total thyroidectomy and at least 1 treatment with RaI., The presence of local or metastatic disease, radiologically proven. A minimum of 1 target lesion (minimum of 1.0 cm for soft tissue and 1.5 cm for lymph nodes) must be present., RaI refractory disease: at least one lesion (target lesion, needs to fulfil the above-mentioned criteria) without therapeutic relevant RaI uptake at previous post-therapeutic RaI scintigraphy and/or negative diagnostic RaI scan., Target lesion must not be eligible for local treatments (radiotherapy, radiofrequency ablation, etc.). In case of multiple lesions, local treatment is allowed, but these lesions are not considered target lesions.
排除标准
- •Contraindications for digoxin: Creatinine clearance < 50 ml/min and/or active kidney disease; Cardiac arrhythmias (history of arrhythmias and arrhythmias at ECG); Electrolyte disorders, Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements., Unwillingness or inability to comply with study and follow-up procedures., Condition of patient which is critical to participate in this study in the discretion of the PI., Rapidly progressive disease in which urgent start with systemic therapy is required., Concomitant drugs that interfere with digoxin metabolism such as P-glycoprotein inductors or inhibitors, including but not limited to penicillamin, sufasalazin, tipranavir, amiodaron, diltiazem, itraconazol, ketoconazol, kinidin, lapatinib, propafenon, vemurafenib, verapamil, azitromycin, claritromycin, erythromycin, roxitromycin, chloroquin, ciclosporin, anti HCV drugs, anti-HIV drugs, hydroxychloroquine., Patients who do not have normal organ and bone marrow function as defined below: Absolute neutrophil count (ANC) >1.5x109/L; Hemoglobin = 9 g/dL; Platelets = 100 x 109/L., Other active malignancies other than basal cell carcinoma. Malignancies that have been in complete remission for >2 years are not considered active malignancies., Pregnancy, lactating or breast-feeding women. Negative pregnancy test is mandatory within 7 days prior to starting the study premenopausal women. Women of non-childbearing potential may be included without pregnancy test if they are either surgically sterile or have been postmenopausal for = 1 year. Fertile men and women must use an effective method of contraception during treatment and for at least 6 months after completion of treatment as directed by their physician. Effective methods of contraception are defined as those, which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly (for example implants, injectables, combined oral contraception or intra-uterine devices). At the discretion of the investigator, acceptable methods of contraception may include total abstinence in cases where the lifestyle of the patient ensures compliance. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception)., Having undergone a CT-scan with contrast agent within the last three months (this would reduce the iodide uptake)., Prior therapy with 131I <6 months prior to initiation of therapy on this protocol. A diagnostic study using <400 MBq of 131I is not considered 131I-therapy., External beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol. (Previous treatment with radiation for any indication is allowed if the investigator judges that the previous radiation does not significantly compromise patient safety on this protocol)., Chemotherapy or targeted therapy (e.g., tyrosine kinase inhibitor) is not allowed < 4 weeks prior to the initiation of therapy on this protocol., Eastern Cooperative Oncology Group (ECOG) score >2., Use of other investigational drugs within 4 weeks preceding the first dose of drug treatment during this study., A known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to the investigational drug.
研究者
相似试验
尚未招募
不适用
Intralesional Injection of Combined Digoxin and Furosemide Versus 5-Flurouracil in Plantar WartsPlantar WartNCT05599971Zagazig University45
撤回
2 期
Digoxin for Patients With Non-alcoholic Steatohepatitis (NASH)Nonalcoholic SteatohepatitisNCT04216693The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
已完成
1 期
Pharmacokinetics, Safety and Tolerability of Digoxin With or Without Co-administration of BI 1356 in Healthy VolunteersHealthyNCT02183402Boehringer Ingelheim20
已完成
1 期
The Pharmacokinetic Study of the Combination of Digoxin and Polythylene Glycol Loxenatide Injection in Healthy SubjectsHealthyNCT02451527First Affiliated Hospital Xi'an Jiaotong University16
已完成
4 期
A Prospective Study of Different Digoxin Treatment Regimens in Egyptian HospitalAtrial FibrillationNCT02489786Cairo University71