A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)
Phase 1
Terminated
- Conditions
- Advanced Pancreatic Adenocarcinoma
- Registration Number
- NCT01050283
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 15
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Association of changes in FDG uptake with overall survival (OS) Week 3 and at least 7 months after the last patient is treated
- Secondary Outcome Measures
Name Time Method Association of metabolic response with OS Baseline, Week 3, and at least 7 months after the last patient is treated Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7 Week 3 and Week 6-7