MR-HYPERPOLARISATION SCANNING WITH HYPERPOLARISED PYRUVATE (13C) IN PANCREATIC CANCER PATIENTS – A FEASIBILITY STUDY
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- C13-Pyruvate spectroscopy imaging generates spectroscopic parameters (quantitative data for lactate, pyruvate, arginine and HCO3-). These will be projected 07-07-22 Projektbeskrivelse: MR-hyperpolarization 8. Version. Page 25 into a high-resolution anatomical image. The quantitative numerical data will be given as ratios, e.g. lactate/pyruvate-ratio, which gives us the possibility to perform comparisons between non-tumor vs. tumor tissue and pre-chemo vs. post-chemo.
研究概览
简要总结
To optimise the MR-hyperpolarisation scanning technique in patients using a dose of 13C-Pyruvate established as safe in previous phase I/II-studies. To obtain baseline data on 13C-Pyruvate MR-hyperpolarisation signals in selected anatomical sites including tumorous pancreas, non-tumorous pancreas, liver metastases and normal liver. To confirm safety and feasibility of infusion of 13C-Pyruvate in patients with pancreatic cancer. To explore correlations between 13C-Pyruvate MR-hyperpolarisation signals and evidence of clinical response to chemotherapy to be tested in further phase II-studies.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with inoperable (metastatic, locally advanced or localised)or relapsedhistologically or cytologically verified pancreatic adenocarcinoma
- •Scheduled for first-line palliative chemotherapy of any type or having received at least 4 cycles of chemotherapy
- •At least 18 years of age
- •WHO performance status 0-2
- •Adequate hematologic and organ function, i.e. ANC at least 1.500/uL Platlet count >100/uL 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 or urin pregnancy test performed at time of inclusion in the study. Safe and highly effective contraception must be used throughout the study meaning either hormonal anti-conception or an anti-fertility intrauterine device. If the partner is non fertile or the patient has no sexual activities, this is also accepted.
- •Danish speaking
- •Able and willing to comply after informed consent
排除标准
- •Contraindications to contrast enhanced MRI
- •Predicted remaining survival <3 months
- •Contraindication to contrast enhanced CT
- •Not able or willing to receive chemotherapy
- •Patients not willing to participate
- •Uncontrolled serious medical condition, such as uncontrolled heart disease, uncontrolled diabetes, intestinal obstruction, uncontrolled hypertension, or recent cerebral ischemia or cardiac events
- •Previous or current radiotherapy or chemotherapy
- •History of acute or chronic pancreatitis
- •Acute or chronic liver disease incl. cirrhosis
- •Intolerant to Pyruvate
结局指标
主要结局
C13-Pyruvate spectroscopy imaging generates spectroscopic parameters (quantitative data for lactate, pyruvate, arginine and HCO3-). These will be projected 07-07-22 Projektbeskrivelse: MR-hyperpolarization 8. Version. Page 25 into a high-resolution anatomical image. The quantitative numerical data will be given as ratios, e.g. lactate/pyruvate-ratio, which gives us the possibility to perform comparisons between non-tumor vs. tumor tissue and pre-chemo vs. post-chemo.
C13-Pyruvate spectroscopy imaging generates spectroscopic parameters (quantitative data for lactate, pyruvate, arginine and HCO3-). These will be projected 07-07-22 Projektbeskrivelse: MR-hyperpolarization 8. Version. Page 25 into a high-resolution anatomical image. The quantitative numerical data will be given as ratios, e.g. lactate/pyruvate-ratio, which gives us the possibility to perform comparisons between non-tumor vs. tumor tissue and pre-chemo vs. post-chemo.
次要结局
未报告次要终点
研究者
Christoffer Laustsen
Scientific
Aarhus Universitet