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临床试验/NCT05730608
NCT05730608招募中不适用

Improving Breast Cancer Staging With 18F-FDG PET/CT Imaging (The IMBRECAS PET Study)

Vestre Viken Hospital Trust2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2023年2月16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
300
试验地点
2
主要终点
Change in staging and/or management due to added 18F-FDG PET/CT scan

研究概览

简要总结

Purpose To investigate the ability of 18F-FDG PET/CT imaging to detect metastases not detected by conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III and locoregional recurrent breast cancer (BC) which can affect the choice of treatment.

Hypothesis The hypothesis is that 18F-FDG PET/CT can provide information about disease stage beyond the currently used conventional imaging (CT and bone scintigraphy) in patients diagnosed with stage II/III or locoregional recurrent BC.

Objectives

Primary:

To evaluate if a 18F-FDG PET/CT scan in the initial work up of patients diagnosed with stage II/III or locoregional recurrent BC will lead to change in staging and/or treatment.

Secondary:

  • Overall survival (OS) and progression-free survival (PFS) in the patients with upstaging based on findings on 18F-FDG PET/CT scan compared with the patients with unchanged stage of disease following 18F-FDG PET/CT.
  • Obtain size of the primary BC from CT/MRI scan and evaluate if these metrics are correlated to outcome.
  • Obtain PET parameters from the primary BC: maximum, mean, and peak standardized uptake value (SUVmax, SUVmean, SUVpeak), metabolic tumour volume (MTV), total lesion glycolysis (TLG), total MTV and total TLG and evaluate if these metrics are correlated with outcome.
  • Obtain CT and PET texture parameters from the primary BC and evaluate if these metrics are correlated with outcome.
  • Blood and tumor samples for molecular characterisation:

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
Single (Participant)

入排标准

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

入选标准

  • Patients with high risk primary or recurrent breast cancer
  • Non pregnant women > 18 years
  • Not receiving active treatment of other cancer types.
  • Eastern Cooperative Oncology Group (ECOG) status 0-2.

排除标准

  • Pregnant woman
  • Age under 18
  • Patients receiving active treatment for other cancers
  • Poor general conditipon (ECOG 3 or higher)

结局指标

主要结局

Change in staging and/or management due to added 18F-FDG PET/CT scan

时间窗: 5 years

Percentage of the patients with change in staging and/or management

次要结局

  • Overall survival(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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