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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET Scan
FLT
FDG
Sponsored by
Stanford University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University School of Medicine

Outcomes

Primary Outcome Measures

Evaluate the performance of the novel imaging methods

Secondary Outcome Measures

Correlate FLT activity with clinical outcomes

Full Information

First Posted
October 3, 2008
Last Updated
June 7, 2012
Sponsor
Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT00767273
Brief Title
Investigate Role of Metabolic Imaging in Predicting Tumor Response/Outcome After Pancreatic CA Tx
Official Title
Pilot Study to Investigate the Role of Metabolic Imaging in Predicting Tumor Response and Outcome After Therapy for Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University

4. Oversight

5. Study Description

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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
PET Scan
Intervention Type
Drug
Intervention Name(s)
FLT
Intervention Type
Drug
Intervention Name(s)
FDG
Primary Outcome Measure Information:
Title
Evaluate the performance of the novel imaging methods
Secondary Outcome Measure Information:
Title
Correlate FLT activity with clinical outcomes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Albert Koong
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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

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