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A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)

This study has been terminated.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT01050283
First received: January 13, 2010
Last updated: March 5, 2013
Last verified: March 2013
History of Changes

January 13, 2010
March 5, 2013
July 2010
May 2012   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01050283 on ClinicalTrials.gov Archive Site
  • Association of metabolic response with OS [ Time Frame: Baseline, Week 3, and at least 7 months after the last patient is treated ] [ Designated as safety issue: No ]
  • Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7 [ Time Frame: Week 3 and Week 6-7 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 1
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Advanced Pancreatic Adenocarcinoma
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.
Experimental: 1
[18F]-FDG-PET/CT (Computed Tomography) Imaging
Intervention: Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
15
May 2012
May 2012   (final data collection date for primary outcome measure)

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
Both
35 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01050283
2010_501, 144
No
Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP