NCT00547612

Brief Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using \[18F\]-labeled substance P antagonist receptor quantifier, may be effective in finding disease in patients with pancreatic cancer. PURPOSE: This phase I trial is studying how well a PET scan using \[18F\]-labeled substance P antagonist receptor quantifier works in finding disease in patients with pancreatic cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P50-P75 for phase_1 pancreatic-cancer

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_1 pancreatic-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 22, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 16, 2012

Status Verified

March 1, 2012

Enrollment Period

1.3 years

First QC Date

October 19, 2007

Last Update Submit

March 14, 2012

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreasstage I pancreatic cancerstage II pancreatic cancerstage III pancreatic cancerstage IV pancreatic cancerrecurrent pancreatic cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography

Interventions

high performance liquid chromatographyOTHER
pharmacological studyOTHER
[18F]-labeled substance P antagonist receptor quantifierRADIATION

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ECOG performance status 0-2
  • WBC ≥ 1,200/mm³
  • Creatinine \< 2.0 mg/dL
  • Negative pregnancy test
  • Fertile patients must agree to use effective contraception
  • Not pregnant or nursing

You may not qualify if:

  • Allergy to IV contrast
  • Claustrophobia that would preclude completion of a scan or unable to lie on one's back for positron emission tomography scan
  • PRIOR CONCURRENT THERAPY:
  • More than 4 weeks since prior abdominal surgery
  • Prior participation in other research protocols within the past year such that a radiation exposure together with the present study would exceed the annual limits
  • Aprepitant within 72 hours of \[18F\]-labeled substance P antagonist receptor quantifier positron emission tomography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Chromatography, High Pressure Liquid

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Chromatography, LiquidChromatographyChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Richard E. Royal, MD, FACS

    NCI - Surgery Branch

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Purpose
DIAGNOSTIC
Sponsor Type
NIH

Study Record Dates

First Submitted

October 19, 2007

First Posted

October 22, 2007

Study Start

September 1, 2007

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 16, 2012

Record last verified: 2012-03

Locations

US(1)