Clinical trialPhase 1Terminated
A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)
A Multicenter Trial to Evaluate 18F-FDG Uptake by PET in Patients With Advanced Pancreatic Adenocarcinoma as an Early Indicator of Drug Activity
- Outcome
- Stopped early
- Phase
- Phase 1
- Status
- Terminated
- Study type
- Interventional
- Start
- July 2010
- Ended
- May 2012
- Enrollment
- 15 participants
- Sites
- 0
- Primary outcomes
- Association of changes in FDG uptake with overall survival (OS)
- Sponsor type
- Industry
- Results posted
- No
- Last update
- 27 July 2015
These fields come from the trial’s registry entry. A summary of its population, design, endpoints and results, each tied to a quote, has not been written for this trial yet.
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Brief summary public domain (ClinicalTrials.gov)
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.
Intervention public domain (ClinicalTrials.gov)
Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT. 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.
Arm public domain (ClinicalTrials.gov)
1 (experimental): \[18F\]-FDG-PET/CT (Computed Tomography) Imaging
Primary outcome public domain (ClinicalTrials.gov)
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 public domain (ClinicalTrials.gov)
Association of metabolic response with OS. Time frame: Baseline, Week 3, and at least 7 months after the last patient is treated.
Secondary outcome public domain (ClinicalTrials.gov)
Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7. Time frame: Week 3 and Week 6-7.
Eligibility public domain (ClinicalTrials.gov)
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
Enrollment public domain (ClinicalTrials.gov)
Enrollment: 15 participants (actual).