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临床试验/NCT05246475
NCT05246475招募中不适用

Simultaneous PET-MRI for Comparison of Advanced DW-MRI Techniques and EF5-PET in the Detection of Hypoxia in Head and Neck Cancer

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年2月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
PET-MRI correlation

研究概览

简要总结

This study is designed to evaluate the performance of advanced magnetic resonance (MR) imaging in the assessment of tumor hypoxia using [18F]EF5 positron emission tomography (PET) as a reference in head and neck cancer patients. Low oxygen level or hypoxia contributes to radiotherapy resistance. Therefore, a clinically applicable method to detect tumor hypoxia is of great importance.

详细描述

This is a non-randomized prospective study which aims to compare [18F]EF5 PET data and MR imaging data acquired with simultaneous PET/MR imaging. Hypoxic tumor tends to be more aggressive than its non-hypoxic counterpart since hypoxia promotes invasive tumor growth and metastatic spread of the disease. The detrimental effect of hypoxia on outcome of radiotherapy (RT) is especially important in head and neck cancer.

EF5 is a comprehensively studied hypoxia-avid compound, which is utilized in radiolabeled form in [18F]EF5 PET imaging detecting tumor hypoxia. IVIM (intra-voxel incoherent motion) is novel technique based on diffusion-weighted MRI (DWI), which allows for the distinction between tissue perfusion and diffusion without the need for intravenous contrast agent. This study aims to investigate the potential of novel MRI techniques for tumor hypoxia assessment in HNC.

The specific aims of the current study are:

  1. To characterize the voxel-level relationship between diffusion characteristics in tumor tissue, as measured with DW-MRI, and tumor hypoxia, as measured with [18F]EF5-PET, leveraging the state-of-the-art simultaneous MRI/PET measurement;
  2. To employ IVIM-based modeling of DW-MRI signal using multiple b-values to optimize the diffusion metrics that most closely predict tumor hypoxia, and compare those with the perfusion metrics from DCE;
  3. To develop models based on novel radiophenotypic analyses of MRI data (radiomics) and machine learning algorithms to find MRI patterns that best predict tumor hypoxia at the patient sample level.

The only intervention for participating subjects is an additional [18F]EF5-PET/MR scan, which is not used for any clinical purposes. All study subjects will undergo standard diagnostic and treatment procedures according to clinical routine.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: 18 to 80 years old
  • Sex: male or female
  • Language spoken: Finnish or Swedish
  • Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
  • Mental status: Patients must be able to understand the meaning of the study
  • Diagnosis: Histological, cytological and clinical findings are consistent with squamous cell carcinoma of the head and neck (oral cavity, pharynx or larynx)
  • Primary tumor diameter as determined clinically or from contrast enhanced CT or MRI scan must be at least 20 mm
  • Patients with nodal neck metastases of head and neck cancer are eligible
  • Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
  • Gravidity: Patient, if female, must not be pregnant or lactating at the time of the study

排除标准

  • Any previously known contraindication of MR Imaging (including but not limited to metallic implants or foreign bodies, pacemakers or other cardiac implantable electronic devices, MR-incompatible prosthetic heart valves, contrast allergy, claustrophobia)
  • Prior Medical History: Patient must have no history of serious haematologic, cardiovascular, liver or kidney disease. Since none of these is an absolute contraindication for inclusion final judgement will be left to the investigators.
  • Prior Therapy: Patient must have no history of previous chemotherapy, biological therapy, immunotherapy, radiotherapy or major surgery for treatment of head and neck cancer
  • Infections: Patient must not have an uncontrolled serious infection
  • Advanced disease: Patient is not eligible for curative cancer treatment due to advanced disease.

结局指标

主要结局

PET-MRI correlation

时间窗: 1 day

Voxel level correlation of DW-MRI and PET estimates

次要结局

未报告次要终点

研究者

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

Jussi Hirvonen

Radiologist

Turku University Hospital

研究点 (2)

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