Back to resultsA Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)
Primary Purpose
Advanced Pancreatic Adenocarcinoma
Status
Terminated
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Comparator: [18F]-FDG PET/CT and Volumetric CT
Sponsored by
About this trial
This is an interventional diagnostic trial for Advanced Pancreatic Adenocarcinoma focused on measuring Advanced pancreatic adenocarcinoma
Eligibility Criteria
Inclusion Criteria:
- Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
- Patient is scheduled to receive standard chemotherapy containing gemcitabine
- Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
- Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution
Exclusion Criteria:
- Patient has had open abdominal surgery within 6 weeks of the screening visit
- Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
- Patient has an active infection, inflammation, or unresolved bowel obstruction
- Patient has poorly controlled diabetes
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
[18F]-FDG-PET/CT (Computed Tomography) Imaging
Outcomes
Primary Outcome Measures
Association of changes in FDG uptake with overall survival (OS)
Secondary Outcome Measures
Association of metabolic response with OS
Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7
Full Information
NCT ID
NCT01050283
First Posted
January 13, 2010
Last Updated
July 24, 2015
Sponsor
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01050283
Brief Title
A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)
Official Title
A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity
Study Type
Interventional
2. Study Status
Record Verification Date
July 2015
Overall Recruitment Status
Terminated
Study Start Date
July 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will determine whether [18F]-fluorodeoxyglucose-positron emission tomography (FDG-PET) can be used to screen for the activity of novel pancreatic cancer treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Advanced Pancreatic Adenocarcinoma
Keywords
Advanced pancreatic adenocarcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
[18F]-FDG-PET/CT (Computed Tomography) Imaging
Intervention Type
Procedure
Intervention Name(s)
Comparator: [18F]-FDG PET/CT and Volumetric CT
Intervention Description
Patients will receive gemcitabine-based therapy as prescribed by their treating physician. FDG-PET/CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy. Volumetric CT scans will be performed at baseline following enrollment, and after 3 and 6-7 weeks of therapy.
Primary Outcome Measure Information:
Title
Association of changes in FDG uptake with overall survival (OS)
Time Frame
Week 3 and at least 7 months after the last patient is treated
Secondary Outcome Measure Information:
Title
Association of metabolic response with OS
Time Frame
Baseline, Week 3, and at least 7 months after the last patient is treated
Title
Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7
Time Frame
Week 3 and Week 6-7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient has a diagnosis of Stage IV pancreatic adenocarcinoma with distant metastases
Patient is scheduled to receive standard chemotherapy containing gemcitabine
Patient has not received prior systemic therapy for advanced pancreatic adenocarcinoma
Patient must be available for periodic blood sampling, study-related assessments, and management at the treating institution
Exclusion Criteria:
Patient has had open abdominal surgery within 6 weeks of the screening visit
Patient has had radiotherapy to the thorax, abdomen, or pelvis within 6 months of the screening visit
Patient has an active infection, inflammation, or unresolved bowel obstruction
Patient has poorly controlled diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)
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