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临床试验/NCT03132090
NCT03132090Unknown不适用

Early Response Monitoring of Systemic Therapies in Patients With Advanced Melanoma by Simultaneous Positron-emission-tomography (PET)/Magnetic Resonance Imaging (MRI)

University Hospital Tuebingen2 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2014年9月29日最近更新:
适应症

试验速览

阶段
不适用
入组人数
106
试验地点
2
主要终点
Early therapy response assessment

研究概览

简要总结

Therapeutic agents used in malignant melanoma treatment such as BRAF/MEK inhibitors and anti-CTLA-4/Anti-PD-1 antibodies go along with harmful side effects in a considerable proportion of patients and treatment costs may cause relevant medical expenditures per month. Currently, therapy response assessment in melanoma patients is performed using RECIST criteria which are based on changes in tumour size. PET/CT combines morphological and metabolic information. Thus, the so-called PERCIST-criteria were introduced integrating change in size and glucose utilization for response assessment in solid tumors. Due to the different mechanism of action these new agents introduce different response patterns increase in tumor size due to inflammation for antibody therapies). In conventional chemotherapies, re-staging is usually performed 3 months after treatment initiation which is the result of empirical investigations. Moreover, it has recently been shown, that response to new targeted therapies can be detected much earlier using PET or functional MR techniques. This forms the rationale for the monitoring of melanoma patients using a combined PET/MR technique after only 2 weeks of therapy initiation. Especially for patients in stage IV with a medium survival time of 12 months, a 2.5 months earlier re-staging and therapy adjustment would have significant consequences for the individual clinical course.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

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

  • patient with diagnosed unresectable malignant melanoma stage IV
  • age: ≥18 years
  • planned systemic therapy with either new therapies (BRAF/MEK inhibitors, Anti-CTLA-4/Anti-PD-1 antibodies) or conventional chemotherapeutics (CTx)
  • clinically indicated routine PET/CT (baseline t0) demonstrating at least one measurable lesion
  • PET/CT for baseline-staging and therapy monitoring (clinical indication required)
  • informed consent

排除标准

  • contraindications for MR-imaging (metal implants, claustrophobia, etc.)
  • contraindications for gadolinium-based contrast agent
  • acute infections or other acute diseases
  • pregnant or breast-feeding women
  • disability for informed consent

结局指标

主要结局

Early therapy response assessment

时间窗: Baseline t0 (1st imaging / start of therapy), early therapy response (study visit) t1 (2 weeks after therapy start), regular therapy response (routine visit) t2 (3 month after therapy start)

Early therapy response assessment by multiparametric hybrid imaging (PET/MRI) two weeks (early time point - study visit) and three months (regular staging) after therapy initiation with regard to optimizing patient management (please note: no therapy change intended based on the imaging at early time point (study visit t1)). Early study imaging data and later regular imaging data have to be compared.

次要结局

  • prognostic capacity of morphological and functional MRI measures(3 month)
  • prognostic value of PET/MRI-specific response(18 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Nina Schwenzer

Prof. Dr. med. Nina Schwenzer (clinical professor & PI)

University Hospital Tuebingen

研究点 (2)

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