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

NCT ID: NCT01050283

Last Updated: 2015-07-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-05-31

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.

Conditions

Advanced Pancreatic Adenocarcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1

\[18F\]-FDG-PET/CT (Computed Tomography) Imaging

Group Type: EXPERIMENTAL

Comparator: [18F]-FDG PET/CT and Volumetric CT

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

144

Identifier Type: -

Identifier Source: secondary_id

0000-144

Identifier Type: -

Identifier Source: org_study_id