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

Study Overview

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

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.

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.

Pancreatic Cancer

OTHER: high performance liquid chromatography
OTHER: pharmacological study
RADIATION: [18F]-labeled substance P antagonist receptor quantifier

070222
07-C-0222
CDR0000570181

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-10-19	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-03-14
First Submitted that Met QC Criteria 2007-10-19	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-03-16
First Posted (ESTIMATED) 2007-10-22	Results First Posted N/A	Last Verified 2012-03

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Non Randomized

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment

Primary Outcome Measures	Measure Description	Time Frame
Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Histologically confirmed adenocarcinoma of the pancreas

Primary or metastatic disease
At least one site of measurable disease
Enrolled in an NCI protocol (either a treatment or screening protocol) such as NCI-05-C-0044 or NCI-05-C-0141

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

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Richard E. Royal, MD, FACS, NCI - Surgery Branch

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Clinical Trial Record