Positron Emission Tomography Using [18F]-Labeled Substance P Antagonist Receptor Quantifier in Finding Disease in Patients With Pancreatic Cancer

NCT ID: NCT00547612

Last Updated: 2012-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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OBJECTIVES:

* Determine whether \[18F\]-labeled substance P antagonist receptor quantifier positron emission tomography can identify pancreatic cancer evident on multiphase CT scan.

OUTLINE: Patients undergo multiphase CT scan of the chest, abdomen, and pelvis. No more than 15 days later, patients receive \[18F\]-labeled substance P antagonist receptor quantifier IV and undergo positron emission tomography over 6 hours.

Blood is collected periodically to measure the metabolism of the radiotracer by high performance liquid chromatography with radioactive detectors.

Conditions

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Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

DIAGNOSTIC

Interventions

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high performance liquid chromatography

Intervention Type OTHER

pharmacological study

Intervention Type OTHER

[18F]-labeled substance P antagonist receptor quantifier

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* 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


* More than 4 weeks since prior abdominal surgery

Exclusion Criteria

* 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:


* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institutes of Health Clinical Center (CC)

NIH

Sponsor Role lead

Principal Investigators

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Richard E. Royal, MD, FACS

Role: STUDY_CHAIR

NCI - Surgery Branch

Locations

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Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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07-C-0222

Identifier Type: -

Identifier Source: secondary_id

CDR0000570181

Identifier Type: -

Identifier Source: secondary_id

070222

Identifier Type: -

Identifier Source: org_study_id

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