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临床试验/NCT06408116
NCT06408116招募中2 期

Predicting Esophageal Cancer Borders Using PET-Imaging PEGASUS

University Hospital Heidelberg1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
入组人数
30
试验地点
1
主要终点
Tumor expansion

研究概览

简要总结

The study examines the diagnostic precision of endosonography, mpMRI and PET/CT in defining tumor boundaries and tumor spread before and after neoadjuvant therapy and definitive surgery.

详细描述

In Germany, around 7,100 people develop esophageal cancer every year. The treatment of esophageal cancer depends on the histology in addition to the location and tumor stage. Squamous cell carcinomas are differentiated from adenocarcinomas. Until distant metastases are present in functionally operable patients, the treatment of esophageal cancer includes a curative approach using surgical resection with, depending on the risk profile, neoadjuvant chemotherapy or neoadjuvant radio(chemo)therapy. In patients who are functionally inoperable or who refuse surgery, definitive radio(chemo)therapy is given. While the histopathological frozen section is available for surgical resection to differentiate tumor tissue from healthy tissue in addition to the surgeon's macroscopic impression, this assistance in defining the target volume is missing in radiation oncology. Instead, the target volume definition is based, in addition to the contrast-enhanced CT image, on a pretherapeutic endoscopic marking of the tumor boundaries. This allows the tumor boundaries to be delineated in radiation planning imaging. In order to detect the potential microscopic and lymphonodal tumor spread, a large target volume is necessary as a safety margin to avoid later field edge recurrences. According to the current standard, this safety distance extends 4-5cm in both cranial and caudal directions beyond the actual tumor findings. Due to the close positional relationships in the mediastinum, this procedure leads to radiation exposure and subsequent toxicity to the surrounding risk organs such as the lungs, heart and spinal cord. The aim of the present study is to correlate the preoperative endosonographic and imaging local tumor extension and lymph node involvement with the histopathological tumor extension and, in the case of neoadjuvant treatment, with the treatment response by using modern imaging of the tumor and the tumor microenvironment in patients with operated esophageal carcinoma. Since there cannot be any information about the histological tumor extent as a gold standard in the case of definitive radiotherapy, the data from operated patients obtained in the study are extrapolated to the patient population of definitive radiotherapy. From these data, hypotheses should be generated about which patient (groups) benefit from a reduction in the target volume in the definitive radiotherapy treatment setting and whether modern multimodal imaging is suitable for monitoring the therapy response.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Histologically confirmed adenocarcinoma or squamous cell carcinoma of the esophagus, including AEG I and AEG II tumors in the primary situation
  • Planned surgical treatment of esophageal carcinoma
  • Possible staging advantage through FAPI PET/CT diagnostics
  • Patient information and written consent
  • > KI 60% or ECOG 0/1 (at least: self-sufficiency)
  • Age ≥ 18 years

排除标准

  • Previous radiation therapy in the tumor region
  • Previous tumor disease with < 5 years of remission
  • Surgical therapy is not functionally or technically possible
  • Distant metastasis
  • Patient is not capable of giving consent
  • Concurrent participation in another clinical trial that could affect the results of this trial or the other trial
  • Illnesses that do not allow the person concerned to assess the nature and scope as well as possible consequences of the clinical study
  • pregnant or breastfeeding women
  • Signs that the person taking part is unlikely to comply with the therapy (e.g. unwillingness to cooperate)

研究组 & 干预措施

Group 1, Surgery

Other

cT1-2 N0, all histologies: primary surgical therapy

干预措施: surgical therapy (Procedure)

Group 2, Chemotherapy and surgery

Other

cT3-4 and/or N+, adenocarcinomas: neoadjuvant chemotherapy, surgical therapy

干预措施: surgical therapy (Procedure)

Group 2, Chemotherapy and surgery

Other

cT3-4 and/or N+, adenocarcinomas: neoadjuvant chemotherapy, surgical therapy

干预措施: Chemotherapy (Drug)

Group 3, chemotherapy, radiotherapy and surgery

Other

cT3-4 and/or N+, squamous cell carcinomas: neoadjuvant radio(chemo)therapy, surgical therapy

干预措施: photon (Radiation)

Group 3, chemotherapy, radiotherapy and surgery

Other

cT3-4 and/or N+, squamous cell carcinomas: neoadjuvant radio(chemo)therapy, surgical therapy

干预措施: surgical therapy (Procedure)

Group 3, chemotherapy, radiotherapy and surgery

Other

cT3-4 and/or N+, squamous cell carcinomas: neoadjuvant radio(chemo)therapy, surgical therapy

干预措施: Chemotherapy (Drug)

结局指标

主要结局

Tumor expansion

时间窗: Before the start of therapy an immediately after the therapy

Number of patients with correlation of tumor expansion measured by histopathology and imaging techniques (Pet-CT)

次要结局

未报告次要终点

研究者

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

Juergen Debus

Department head

University Hospital Heidelberg

研究点 (1)

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