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

Study Overview

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

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.

N/A

Advanced Pancreatic Adenocarcinoma

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

0000-144
144

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2010-01-13	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-07-24
First Submitted that Met QC Criteria 2010-01-14	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-07-27
First Posted (ESTIMATED) 2010-01-15	Results First Posted N/A	Last Verified 2015-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/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 followi

Participant Group/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 followi

Primary Outcome Measures	Measure Description	Time Frame
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	Measure Description	Time Frame
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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
35 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

STUDY_DIRECTOR: Medical Monitor, Merck Sharp & Dohme LLC

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record