Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

NCT ID: NCT01492907

Last Updated: 2014-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-04-30

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.

Conditions

Pancreatic Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Healthy Control Participants

age/sex matched normal controls - the subject will swallow a capsule with a dietary relevant dose of MeIQx

Group Type: ACTIVE_COMPARATOR

MeIQx

Intervention Type: RADIATION

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.

Pancreatic Cancer Patients

Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.

Group Type: ACTIVE_COMPARATOR

MeIQx

Intervention Type: RADIATION

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.

Pancreatectomy

Intervention Type: PROCEDURE

Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.

Interventions

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.

Intervention Type: RADIATION

Pancreatectomy

Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.

Intervention Type: PROCEDURE

Other Intervention Names

[14C]-MeIQx (2 Amino-3,8-dimethylimidazo[4,5 f]quinoxaline-2-[14C])

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin E. Anderson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Masonic Cancer Center, University of Minnesota

Locations

Masonic Cancer Center, University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

2011NTLS016

Identifier Type: -

Identifier Source: org_study_id