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

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ClinicalTrials.gov Identifier: NCT01050283
Recruitment Status : Terminated
First Posted : January 15, 2010
Last Update Posted : July 27, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Advanced Pancreatic Adenocarcinoma Procedure: Comparator: [18F]-FDG PET/CT and Volumetric CT Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : July 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
[18F]-FDG-PET/CT (Computed Tomography) Imaging
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.


Outcome Measures

Primary Outcome Measures :
  1. 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 Measures :
  1. Association of metabolic response with OS [ Time Frame: Baseline, Week 3, and at least 7 months after the last patient is treated ]
  2. Correlation between FDG standardized uptake values (SUV) at Week 3 and Week 6-7 [ Time Frame: Week 3 and Week 6-7 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01050283


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01050283     History of Changes
Other Study ID Numbers: 0000-144
144
First Posted: January 15, 2010    Key Record Dates
Last Update Posted: July 27, 2015
Last Verified: July 2015

Keywords provided by Merck Sharp & Dohme Corp.:
Advanced pancreatic adenocarcinoma

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action