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Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

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Trial Information

Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer


This is not a therapeutic trial. It is an etiologic investigation of meat-borne carcinogens
and possible role in pancreatic cancer.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Blood

Outcome Description:

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.

Outcome Time Frame:

Pre MeIQx Administration, 1/2, 1, 2, 4, 6, 8 Hours Post MeIQx Administration

Safety Issue:

No

Principal Investigator

Kristin E. Anderson, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Food and Drug Administration

Study ID:

2011NTLS016

NCT ID:

NCT01492907

Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Pancreatic Cancer
  • Heterocyclic amine carcinogens
  • meat-borne carcinogens
  • Pancreatic Neoplasms

Name

Location

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455