Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Urine
研究概览
简要总结
Study Design:
This is a single institution pilot study to recruit 4 patients with operable pancreatic cancer scheduled for a pancreatectomy and 4 age/sex matched normal controls. Both groups will receive a single oral dose of radiolabeled MelQx followed by serial blood draws over an 8 hour period and urine collections over a 24 hour period. In addition, normal pancreatic tissue and normal small bowel tissue will be collected by Tissue Procurement from resected (waste) tissue at the time of pancreatectomy on the 4 pancreatic cancer patients.
详细描述
This is not a therapeutic trial. It is an etiologic investigation of meat-borne carcinogens and possible role in pancreatic cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Cancer cases are eligible for participation if all of the following criteria are met:
- •Diagnosis or suspected diagnosis of pancreatic or periampullary cancer that is deemed to be operable and for which a pancreatectomy is planned.
- •At least 18 years of age.
- •Adequate hepatic function within 4 weeks of study enrollment defined as:
- •Bilirubin ≤ 2 mg/dl
- •aspartate aminotransferase (ALT), alanine aminotransferase (AST), alkaline phosphatase ≤ 2 the upper limit of normal (ULN)
- •Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 2 weeks after MelQx administration.
- •Voluntary written consent before performance of any study-related procedure not part of normal medical care
- •Healthy controls are eligible for participation if all of the following criteria are met:
- •Consider themselves generally healthy.
- •At least 18 years of age
- •Controls will be gender and age matched within 10 years of cases.
- •Adequate hepatic function within 4 weeks of study enrollment defined as:
- •Bilirubin ≤ 2 mg/dl
- •ALT, AST, alkaline phosphatase ≤ 2 the upper limit of normal (ULN)
- •Females of childbearing potential or males whose partners are of child bearing potential are required to use an effective method of contraception (ie, a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study and for 2 weeks after MelQx administration.
- •Voluntary written consent before performance of any study-related procedure not part of normal medical care
排除标准
- •Cancer cases are not eligible for participation if any of the following criteria are met:
- •For the purposes of this study to reduce the risk of recruiting a potentially unresectable patient:
- •Tumor ≥ 3 cm by scan
- •CA-19-9 > 400
- •Pregnant or lactating
- •Uncontrolled chronic conditions such as: cardiovascular disease, hypertension, angina, congestive obstructive pulmonary disease (COPD) or other conditions which may alter metabolism, other than diabetes.
- •Healthy controls are not eligible for participation if any of the following criteria are met:
- •Pregnant or lactating.
- •Uncontrolled chronic conditions such as cardiovascular disease, hypertension, angina, COPD or conditions which may alter metabolism including diabetes.
研究组 & 干预措施
Healthy Control Participants
age/sex matched normal controls - the subject will swallow a capsule with a dietary relevant dose of MeIQx
干预措施: MeIQx (Radiation)
Pancreatic Cancer Patients
Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.
干预措施: MeIQx (Radiation)
Pancreatic Cancer Patients
Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.
干预措施: Pancreatectomy (Procedure)
结局指标
主要结局
Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Urine
时间窗: 0-4, 4-8 and 8-24 Hours Post MeIQx Administration
Metabolite levels will be expressed as the percent of total recovered radioactivity in urine. Metabolite profiles will be qualitatively compared between cases and controls, which will include the mean, median, standard deviation, range and 90% confidence interval for the major detoxification metabolites.
Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Blood
时间窗: Pre MeIQx Administration, 1/2, 1, 2, 4, 6, 8 Hours Post MeIQx Administration
Metabolite levels will be expressed as the percent of total recovered radioactivity in plasma. Metabolite profiles will be qualitatively compared between cases and controls, which will include the mean, median, standard deviation, range and 90% confidence interval for the major detoxification metabolites.
次要结局
- Quantify ambient adducts in the human pancreas(4-8 Hours Post Administration)
- Quantify [14C]MeIQx-DNA adducts in human pancreas(4-8 Hours Post MeIQx Administration)