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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00767273
• Other study ID #: PANC0004
• Secondary ID: 95733SU-11052007
• Status: Completed
• Phase: N/A
• First received: October 3, 2008
• Last updated: June 7, 2012
• Start date: October 2006
• Est. completion date: December 2007

Study information

• Verified date: June 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Procedure:
• PET Scan

Drug:
• FLT

• FDG

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the performance of the novel imaging methods		unknown	No
Secondary	Correlate FLT activity with clinical outcomes		unknown	No