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临床试验/NCT06753903
NCT06753903招募中不适用

Role of Photon Counting CT in Detecting Liver Metastatis From Colorectal Cancer

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年3月24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
100
试验地点
1
主要终点
PCD-CT predictor of response to treatment in patients candidate to chemotherapy

研究概览

简要总结

Colorectal cancer is the first leading cause of cancer death in men and second in women. Its incidence rates also increased by 1%-2% annually in young adults (ages <55 years). The liver is the most common site of colorectal cancer metastasis, with approximately 25% 50% of patients developing liver metastases during the disease. Maximising resection of liver metastasis using all available techniques remains a key objective and provides the best chance of long-term survival and cure. For unresectable patients, optimal systemic and locoregional chemotherapeutic, biological and radiotherapeutic treatments improve survival, and may convert initially unresectable patients to operability. Computed Tomography is currently the modality of choice for patients staging and restaging for high spatial resolution providing accurate delineation of lesion, vascular structure and relation with surrounding structure. The portal venous phase (approximately 60-70 s after administration of contrast agent) is the most reliable phase for detection of liver metastasis with a detection rate of 85% with lower performance for lesion <1 cm which are interpreted as too small to characterize. Compared to computed tomography, MRI has superior soft tissue contrast and the possibly of a multiparametric characterization of lesion thanks to the evaluation of diffusivity and the uptake of hepatospecific contrast media, resulting in higher accuracy also for lesion smaller than < 10 mm. Photon-counting detector computed tomography (PCD-CT), used as standard clinical practice, by employing a reduced radiation dose, allows the acquisition of ultra-high resolution images (up to 169 microns) and spectral information, with a high detection rate of liver metastases and their characterization.

Therefore, aim of the present study is to evaluate the value of PCD-CT in the detection of liver metastasis from colorectal cancer in comparison to MRI as reference standard.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •adult (>18 years)
  • •non- biopsy-proven colon/colorectal carcinoma
  • •CT performed on a PCD-CT
  • •MRI with multiparametric protocol and hepatospecific contrast media

排除标准

  • •pregnancy and breastfeeding
  • •CT exam performed on a scan different from PCD-CT
  • •absence of multiparametric MRI
  • •MRI with non hepatospecific contrast agent
  • •Absent informed consent signed

结局指标

主要结局

PCD-CT predictor of response to treatment in patients candidate to chemotherapy

时间窗: 3 years

The non-inferiority of PCD-CT compared to MRI in identifying liver metastases from colorectal cancer

时间窗: 3 years

次要结局

  • the utility of machine learning-driven texture analysis in detecting prognostic imaging biomarkers for liver metastasis survival, with predictive performance measured by the concordance index.(3 years)

研究者

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

Antonio Esposito

Professor

IRCCS San Raffaele

研究点 (1)

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