- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01050283
A Study to Evaluate [18F]-FDG PET (Fluorodeoxyglucose-positron) in Patients With Pancreatic Cancer (MK-0000-144)
July 24, 2015 updated by: Merck Sharp & Dohme LLC
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Phase 1
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.
Eligibility Criteria
Ages Eligible for Study
35 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
[18F]-FDG-PET/CT (Computed Tomography) Imaging
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Week 3 and at least 7 months after the last patient is treated
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Association of metabolic response with OS
Time Frame: Baseline, Week 3, and at least 7 months after the last patient is treated
|
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
Time Frame: Week 3 and Week 6-7
|
Week 3 and Week 6-7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start
July 1, 2010
Primary Completion (Actual)
May 1, 2012
Study Completion (Actual)
May 1, 2012
Study Registration Dates
First Submitted
January 13, 2010
First Submitted That Met QC Criteria
January 14, 2010
First Posted (Estimate)
January 15, 2010
Study Record Updates
Last Update Posted (Estimate)
July 27, 2015
Last Update Submitted That Met QC Criteria
July 24, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0000-144
- 144
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Advanced Pancreatic Adenocarcinoma
-
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M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingBorderline Resectable Pancreatic Adenocarcinoma | Resectable Pancreatic Ductal Adenocarcinoma | Locally Advanced Pancreatic Ductal AdenocarcinomaUnited States
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Changhai HospitalCARsgen Therapeutics Co., Ltd.UnknownPancreatic Adenocarcinoma | Advanced Gastric AdenocarcinomaChina
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HonorHealth Research InstituteActive, not recruitingLocally Advanced Pancreatic Adenocarcinoma | Borderline Resectable Pancreatic Adenocarcinoma | Untreated Resectable Pancreatic AdenocarcinomaUnited States
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