Pancreatic CancerPhase 1NCT01492907
Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer
A Phase 1 study testing MeIQx and Pancreatectomy in people with Pancreatic Cancer, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pancreatic Cancer
- What is being tested?
- MeIQx and Pancreatectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2012to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
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.
Read the 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
- Being tested
- MeIQx, Pancreatectomy
- Keywords
- Heterocyclic amine carcinogens, meat-borne carcinogens
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MeIQxRadiation
Also called [14C]-MeIQx (2 Amino-3,8-dimethylimidazo[4,5 f]quinoxaline-2-[14C])
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.
PancreatectomyProcedure or surgery
Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Control Participants | Active comparator | age/sex matched normal controls - the subject will swallow a capsule with a dietary relevant dose of MeIQx Receives: Radiation: MeIQx |
| Pancreatic Cancer Patients | Active comparator | Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center. Receives: Radiation: MeIQx; Procedure: Pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre MeIQx Administration, 1/2, 1, 2, 4, 6, 8 Hours Post MeIQx Administration
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.
Measured: 0-4, 4-8 and 8-24 Hours Post MeIQx Administration
Secondary outcomes (2)
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).
Measured: 4-8 Hours Post MeIQx Administration
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).
Measured: 4-8 Hours Post Administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristin E. Anderson, Ph.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01492907
- Sponsor's protocol ID
- 2011NTLS016
- Status last verified
- Aug 2014
- First submitted
- 13 Dec 2011
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Meat-Borne Carcinogens and Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT01492907
- Acronym / sponsor ID
- 2011NTLS016
- Conditions
- Pancreatic Cancer
- Keywords
- Heterocyclic amine carcinogens, meat-borne carcinogens
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 15 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy Control Participants | Active comparator | Radiation: MeIQxage/sex matched normal controls - the subject will swallow a capsule with a dietary relevant dose of MeIQx |
| Pancreatic Cancer Patients | Active comparator | Radiation: MeIQx, Procedure: PancreatectomyPatients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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:
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MeIQxAlso: [14C]-MeIQx (2 Amino-3,8-dimethylimidazo[4,5 f]quinoxaline-2-[14C])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. | Radiation | Healthy Control Participants, Pancreatic Cancer Patients |
| PancreatectomyPatients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center. | Procedure or surgery | Pancreatic Cancer Patients |
Primary outcome
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.
2 secondary outcomes
Quantify [14C]MeIQx-DNA adducts in human pancreas
Time frame: 4-8 Hours Post MeIQx Administration
Quantify ambient adducts in the human pancreas
Time frame: 4-8 Hours Post Administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin E. Anderson, Ph.D. principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MeIQx and Pancreatectomy in people with Pancreatic Cancer, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetic Metabolite Profile of Radiolabeled MeIQx in Blood (time frame: Pre MeIQx Administration, 1/2, 1, 2, 4, 6, 8 Hours Post MeIQx Administration). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2014; AzTrials last refreshed its copy on 8 Nov 2026.