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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01050283

Enrollment

Registered

2010-01-15

Start date

2010-07-31

Completion date

2012-05-31

Last updated

2015-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Pancreatic Adenocarcinoma

Keywords

Advanced pancreatic adenocarcinoma

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.

Interventions

PROCEDUREComparator: [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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026