Investigate Role of Metabolic Imaging in Predicting Tumor Response/Outcome After Pancreatic CA Tx

June 7, 2012 updated by: Albert Koong, Stanford University

Pilot Study to Investigate the Role of Metabolic Imaging in Predicting Tumor Response and Outcome After Therapy for Pancreatic Cancer

To test the ability of new imaging techniques to monitor and predict response of pancreatic cancer to radiation and/or chemotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- Adult patients (>18) with histologically confirmed adenocarcinomas of the pancreas with a - treatment plan consisting of definitive or palliative radiation therapy and/or chemotherapy with or without surgery.

  • Negative urine pregnancy test if a woman of child-bearing potential (WOCBP).
  • WOCBP must be using an adequate method of contraception to avoid pregnancy throughout the study period.

  • All patients will be evaluated in a uniform manner at the Stanford GI Combined Modality Tumor Board to determine eligibility. Exclusion Criteria:1. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.

    2. Any concurrent malignancy other than non-melanomaskin cancer, or carcinomainsitu of the cervix. Patients with a previous malignancy without evidence of disease for >5 years will be allowed to enter the trial.

    3. WOCBP who is pregnant or breastfeeding. 4. Inability to sign written consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Evaluate the performance of the novel imaging methods

Secondary Outcome Measures

Outcome Measure
Correlate FLT activity with clinical outcomes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

October 3, 2008

First Submitted That Met QC Criteria

October 6, 2008

First Posted (Estimate)

October 7, 2008

Study Record Updates

Last Update Posted (Estimate)

June 11, 2012

Last Update Submitted That Met QC Criteria

June 7, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PANC0004
  • 95733
  • SU-11052007-795 (Other Identifier: Stanford University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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