NL-OMON49926招募中2 期
Pilot study of FAPI PET/CT for locoregional (re)staging of lymph nodes in colorectal carcinoma - FAPI CRC -1
Antoni van Leeuwenhoek Ziekenhuis0 个研究点目标入组 30 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
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 99（—）
入选标准
- •Biopsy proven newly detected adenocarcinoma of the colon or rectum
- •cT(any) N1-2 M(any) using TNM 8th edition and based on standard diagnostic
- •imaging including contrast enhanced-CT thorax-abdomen (for colon and rectum)
- •and pelvic MRI (for rectum)
- •Indication for curative local treatment of the primary colon/rectal tumour
- •Signed written informed consent prior to any study specific procedure
- •For colon cancer patients:
- •Age 18 years and older
- •Indication for surgery including resection of the colon tumour and the
- •corresponding mesentery
- •Surgery can be planned within 5 weeks after diagnostic imaging
- •Surgery takes place in one of the participating centres of this study
- •For rectal cancer patients:
- •Age 50 years and older
- •Indication for neoadjuvant (chemo)radiotherapy of the rectal tumour
- •Planned for response assessment after (chemo)radiotherapy with pelvic MRI
- •Planned for surgery or an organ preservation approach in one of the
- •participating centres of this study
排除标准
- •Histopathology of mucinous adenocarcinoma
- •Inability to provide informed consent
- •Pregnancy
- •Lactation, unable to substitute for 24 hours after FAPI PET/CT
- •Known second malignant disease that may complicate image interpretation
- •including a second primary at time of diagnosis CRC
- •Inability to cooperate with the scan process: inability to lie relatively
- •still and in supine for 30-60 minutes or patient body habitus above scanner
- •Suspicion of peritoneal metastases based on contrast-enhanced CT and/or MRI
- •Treatment setting without local treatment of the primary colorectal tumour
- •For colon cancer patients:
- •Absence of diagnostic contrast enhanced-CT thorax-abdomen
- •Refusal of surgery by the patient
- •Indication for neoadjuvant treatment
- •Indication for emergency surgery
- •For rectal cancer patients:
- •Contra-indication for MRI
- •Absence of diagnostic pelvic MRI and/or contrast enhanced-CT thorax-abdomen
- •Refusal of neoadjuvant treatment by the patient
- •Absence of response assessment after (chemo)radiotherapy
研究者
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