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Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01492907
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE December 13, 2011
First Posted Date  ICMJE December 15, 2011
Last Update Posted Date August 22, 2014
Study Start Date  ICMJE January 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2012)
  • Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Blood [ Time Frame: 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.
  • Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Urine [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 14, 2011)
Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx [ Time Frame: 24 Hours Post MeIQx Administration ]
Metabolite levels will be expressed as the percent of total recovered radioactivity in plasma or 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.
Change History Complete list of historical versions of study NCT01492907 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 31, 2012)
  • Quantify [14C]MeIQx-DNA adducts in human pancreas [ Time Frame: 4-8 Hours Post MeIQx Administration ]
    In the pancreatic cancer patients, uninvolved/normal resected (waste) tissue from the surgery will be sent to Lawrence Livermore National Laboratory (LLNL) for DNA extraction following previously published methods. New [14C]MeIQx-DNA adducts formed at physiological concentrations will be detected and quantified in resected tissue with highly sensitive accelerator mass spectrometry (AMS).
  • Quantify ambient adducts in the human pancreas [ Time Frame: 4-8 Hours Post Administration ]
    DNA adducts already present in resected tissue will be quantified and characterized with a newly improved technique, electrospray capillary high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 14, 2011)
  • Quantify [14C]MeIQx-DNA adducts in human pancreas [ Time Frame: 24 Hours Post MeIQx Administration ]
    In the pancreatic cancer patients, uninvolved/normal resected (waste) tissue from the surgery will be sent to LLNL for DNA extraction following previously published methods. New [14C]MeIQx-DNA adducts formed at physiological concentrations will be detected and quantified in resected tissue with highly sensitive AMS.
  • Quantity of ambient adducts in the human pancreas [ Time Frame: 24 Hours Post Administration ]
    DNA adducts already present in resected tissue will be quantified and characterized with a newly improved technique, electrospray capillary high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer
Official Title  ICMJE Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer
Brief Summary

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.

Detailed Description This is not a therapeutic trial. It is an etiologic investigation of meat-borne carcinogens and possible role in pancreatic cancer.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE
  • Radiation: MeIQx
    On the day of administration, the subject will swallow a capsule with a dietary relevant dose of MeIQx, 21 µg, labeled with a very low level of 14-carbon. The radioactive dose for MeIQx, 0.002 mSv (4.3 µCi), or less than an average dental x-ray.
    Other Name: [14C]-MeIQx (2 Amino-3,8-dimethylimidazo[4,5 f]quinoxaline-2-[14C])
  • Procedure: Pancreatectomy
    Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.
Study Arms  ICMJE
  • Active Comparator: Healthy Control Participants
    age/sex matched normal controls - the subject will swallow a capsule with a dietary relevant dose of MeIQx
    Intervention: Radiation: MeIQx
  • Active Comparator: Pancreatic Cancer Patients
    Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.
    Interventions:
    • Radiation: MeIQx
    • Procedure: Pancreatectomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 14, 2011)
8
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Cancer cases are eligible for participation if all of the following criteria are met:

  • 1. 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

Exclusion Criteria:

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
  • Ascites
  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01492907
Other Study ID Numbers  ICMJE 2011NTLS016
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kristin E. Anderson, Ph.D. Masonic Cancer Center, University of Minnesota
PRS Account University of Minnesota
Verification Date August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP