NCT01050283

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2010

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 15, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

July 27, 2015

Status Verified

July 1, 2015

Enrollment Period

1.8 years

First QC Date

January 13, 2010

Last Update Submit

July 24, 2015

Conditions

Advanced Pancreatic Adenocarcinoma

Keywords

Advanced pancreatic adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • Association of changes in FDG uptake with overall survival (OS)

    Week 3 and at least 7 months after the last patient is treated

Secondary Outcomes (2)

  • 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

Study Arms (1)

1

EXPERIMENTAL

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

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

Interventions

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

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.

1

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2010

First Posted

January 15, 2010

Study Start

July 1, 2010

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

July 27, 2015

Record last verified: 2015-07