Early detection of effects of chemotherapy in pancreatic cancer patients –a study using MR-hyperpolarization scanning based on hyperpolarized Pyruvate (13C) injection

Dept. Clinical Medicine, Aarhus Universit0 个研究点目标入组 15 人开始时间: 2017年1月3日最近更新: 2022年8月8日

适应症

试验速览

暂无简介。

•Inclusion criteria
•Patients with inoperable (metastatic, locally advanced or localised) histologically or cytologically verified pancreatic adenocarcinoma.
•Scheduled for first-line palliative chemotherapy of any type.
•At least 18 years of age.
•WHO performance status 0-2.
•Measurable or unmeasurable disease.
•Adequate hematologic and organ function, i.e.
•ANC at least 1.5
•Platlet count >100
•Se bilirubin <1.5 UNL
•ASAT, ALAT and AP up to 2.5 x UNL, up to 5 x UNL with liver metastases
•Se creatinine up to 1.5 x UNL or creatinine clearance at least 30 ml/min
•INR and aPTT at most 1.5 x UNL, except for patients on AK treatment
•Women who are not postmenopausal or surgically sterile must have a negative serum pregnancy test. Safe contraception should be used throughout the study for all other patients.
•Danish speaking
•Able and willing to comply after informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 5

•Patients in whom treatment is curatively intended, e.g. patients scheduled for preoperative treatment of marginally resectable disease
•Contraindications to contrast enhanced MRI
•Contraindication to contrast enhanced CT
•Not able or willing to receive chemotherapy
•Patients not willing to participate

发起方

Dept. Clinical Medicine, Aarhus Universit