PET-CT and DWI-MRI in evaluating and predicting response to neoadjuvant chemoradiotherapy in esophageal cancer patients: PET/MRI-OES-1 study - PET-CT vs DWI-MRI and response in esophageal ca.

niversitair Medisch Centrum Groningen0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月23日

试验速览

暂无简介。

•In order to be eligible to participate in this study, a subject must meet all of the following criteria:
•1. Histologically proven esophageal cancer (SCC and AC).
•2. Age 18 years or older.
•3. Able to give written informed consent before registration.
•4. T2-T4aN0M0 or T1-T4aN1-3M0 esophageal cancer.
•5. Potentially curatively (R0) resectable tumor.
•6. Tumor should have sufficient FDG-baseline uptake (in case routine baseline FDG-PET/CT shows insufficient uptake no additional MRI will be made).
•7. Able to tolerate PET-CT and DWI-MRI as required by protocol.
•8. Patients eligible for neo-adjuvant chemoradiotherapy (CRT), including a Karnofsky Performance Score (KPS) >= 70% / WHO>2, adequate renal, hepatic, hematological function.
•9. No prior chemotherapy or mediastinal radiotherapy allowed.
•10. Written informed consent.

•A potential subject who meets any of the following criteria will be excluded from participation in this study:
•1. Non-resectable tumours
•2. Proven distant metastases
•3. Prior malignancy except in-situ cervical lesions and/or non-melanoma skin cancer in the past 5 years.
•4. Poorly controlled diabetes
•5. Medical comorbidity preventing from surgery/preop CRT
•6. General contraindications to MRI:
•- implanted pacemaker/serious claustrophobia
•- aneurysmal clips/metal implants in field of view
•6. Major obesity (BMI > 40)
•7. Active esophagitis
•8. Breast feeding/Pregnancy

发起方