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临床试验/CTIS2023-506594-35-00
CTIS2023-506594-35-00进行中(未招募)1 期

[68Ga]Ga-FAPI-46 positron emission tomography for detection of lymph node metastasis in early rectal cancer (FARE Trial)

Amsterdam UMC0 个研究点目标入组 45 人开始时间: 2023年7月27日最近更新:
适应症

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
45

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 65+(—)
性别
All

入选标准

  • Group A: Patients aged =18 years with suspected or confirmed cT1-3N0-1M0 rectal cancer, defined as tumour invasion not extending beyond the perirectal tissue on standard MRI, with or without evidence of locoregional LNM on MRI, and no evidence of distant metastases on chest and abdominal CT., Group A: Scheduled for primary TME (i.e. without prior local excision and without neo-adjuvant treatment)., Group A: Approval of the local multidisciplinary colorectal tumour board for performing primary TME., Group B: Patients aged =18 years with suspected or confirmed cT1-2N0M0 rectal cancer, defined as tumour invasion not beyond the muscularis propria on standard MRI, no evidence of LNM on MRI, and no evidence of distant metastases on chest and abdominal CT., Group B: Tumours with endoscopic features of deep submucosal/muscularis propria invasion defined as: NBI: Hiroshima C2/3, JNET 3, NICE III, or chromoendoscopy: Kudo Vn pit pattern and/or the presence of non-lifting in the presence of features of submucosal invasion (Hiroshima C1, JNET 2B, Kudo Vi pit pattern), thus a tumour suitable for local excision., Group B: Planned local excision using either EID or TAMIS., Group B: Approval of the local multidisciplinary colorectal tumour board for performing (diagnostic) local excision.

排除标准

  • Group A & B: Not able to communicate in Dutch or English, Group A & B: Neoadjuvant treatment (for current diagnosis of rectal cancer), Group A & B: Pregnant (either the patient or someone in the same household) or lactating women

研究者

发起方
Amsterdam UMC

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