2024-518495-31-00招募中2 期
68Ga/177Lu-PSMA theranostics in recurrent grade 3 and grade 4 glioma
Norwegian University Of Science And Technolology1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2024年10月14日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Evaluation of safety and tolerability: o Type, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Attachment 1) and change in score in the modified RAI-6 questionnaire (Attachment 2).
研究概览
简要总结
• To evaluate safety and tolerability of 177Lu- PSMA • To evaluate efficacy of 177Lu- PSMA in the treatment of patients with recurrent or progressed grade 3 and grade 4 glioma
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •A previous diagnosis of histologically confirmed WHO grade 3 or grade 4 glioma
- •Women of childbearing potential (WOCBP) defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile must use adequate contraception. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy.
- •Patient accept not to receive any other tumor directed treatment during a treatment cycle (6-8 weeks)
- •Radiologically (MRI) confirmed tumor relapse/progression ≥ 12 weeks since completed radiotherapy or suspicion of recurrence where inclusion in the theranostic part of study could be indicated
- •Must be ≥ 18 years old
- •Written informed consent for study participation
- •Negative pregnancy test no longer than 14 days prior to enrollment
- •Life expectancy > 12 weeks
- •Karnofsky performance status ≥ 70% (must be able to care for self after radionuclide therapy)
- •High tumor uptake on diagnostic imaging with 68Ga -PSMA
- •Tumor not amendable for radiotherapy or surgery, and treating oncologist think that there are no other preferable systemic therapy options (e.g temozolomide, PCV or lomustine monotherapy)
排除标准
- •Estimated GFR < 30 mL/min
- •Breastfeeding
- •Hypersensitivity to the active substance or to any of the excipients
- •Urinary and fecal incontinence (patient cannot have diaper needs)
- •Significant medical or psychiatric illness that, in the investigator's opinion, would compromise the patient's ability to tolerate this therapy
- •If previous radiotherapy and/or radionuclide therapy have resulted in absorbed doses >=23 Gy to any of the kidneys, or >= 25 Gy to any of the parotids, an individual assessment will be made by the nuclear medicine physician and medical physicist if patient can be included to the therapy part of the study
- •Concurrent investigational drugs or experimental therapy must be stopped at least 4 weeks prior to study entry
- •Unwilling to accept potential challenge with xerostomia
- •Platelet count <75 x109 /L
- •White blood cells ≤ 2.0 x 109/L
- •Neutrophil count < 1.5 x109 /L
- •Hb < 10.0 g/dL
- •Albumin ≤ 30 g/L
- •Uncontrollable symptomatic epilepsy refractory to standard medication
- •Pacemakers or defibrillators not compatible with 3T MRI
- •No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits)
结局指标
主要结局
Evaluation of safety and tolerability: o Type, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Attachment 1) and change in score in the modified RAI-6 questionnaire (Attachment 2).
Evaluation of safety and tolerability: o Type, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Attachment 1) and change in score in the modified RAI-6 questionnaire (Attachment 2).
Evaluation of efficacy of 177Lu- PSMA: Progression free survival (6 months) and overall survival (1 year) determined from date of commencement of 177Lu-PSMA therapy
Evaluation of efficacy of 177Lu- PSMA: Progression free survival (6 months) and overall survival (1 year) determined from date of commencement of 177Lu-PSMA therapy
次要结局
- Evaluate radiation dose to tumor and critical organs: Calculation of absorbed doses to the tumor and kidneys, parotid glands, sublingual glands, submandibular glands, lacrimal glands, liver, spleen and red marrow for each therapy cycle as well as accumulated doses for all therapy cycles.
- Evaluate efficacy and side effects of treatment on the following from baseline to end of each treatment cycle and to the follow up examinations: o Tumor responses as assessed by contrast enhanced MRI according to response assessment in neuro oncology (RANO) criteria and volume measurements. o Neurologic exam (nano score) o Health-related quality of life EQ-5D scores o Karnofsky performance status
- Evaluate diagnostic and theranostic properties of 68Ga-PSMA
研究者
Tora Skeidsvoll Solheim
Scientific
Norwegian University Of Science And Technolology
研究点 (1)
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