Back to results

Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

MeIQx

Pancreatectomy

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring Heterocyclic amine carcinogens, meat-borne carcinogens

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Masonic Cancer Center, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Healthy Control Participants

Pancreatic Cancer Patients

Arm Description

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Blood

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

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.

Secondary Outcome Measures

Quantify [14C]MeIQx-DNA adducts in human pancreas

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

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).

Full Information

NCT ID

NCT01492907

First Posted

December 13, 2011

Last Updated

August 21, 2014

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT01492907

Brief Title

Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

Official Title

Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

April 2013 (Actual)

Study Completion Date

April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

Heterocyclic amine carcinogens, meat-borne carcinogens

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Healthy Control Participants

Arm Type

Active Comparator

Arm Description

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

Arm Title

Pancreatic Cancer Patients

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Radiation

Intervention Name(s)

MeIQx

Other Intervention Name(s)

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

Intervention Description

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

Procedure

Intervention Name(s)

Pancreatectomy

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Blood

Description

Time Frame

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

Title

Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Urine

Description

Time Frame

0-4, 4-8 and 8-24 Hours Post MeIQx Administration

Secondary Outcome Measure Information:

Title

Quantify [14C]MeIQx-DNA adducts in human pancreas

Description

Time Frame

4-8 Hours Post MeIQx Administration

Title

Quantify ambient adducts in the human pancreas

Description

Time Frame

4-8 Hours Post Administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kristin E. Anderson, Ph.D.

Organizational Affiliation

Masonic Cancer Center, University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

Masonic Cancer Center, University of Minnesota

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer

We'll reach out to this number within 24 hrs