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

March 14, 2012 updated by: National Institutes of Health Clinical Center (CC)

Pilot Trial of the NK1 Receptor Radio-Ligand [18F]SPA-RQ: Imaging Pancreatic Ductal Adenocarcinoma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

33

Phase

  • Phase 1

Contacts and Locations

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

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892-1182
        • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

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

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:

Inclusion criteria:

  • More than 4 weeks since prior abdominal surgery

Exclusion criteria:

  • 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

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Proportion of tumors detected by [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.

Sponsor

National Institutes of Health Clinical Center (CC)

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Richard E. Royal, MD, FACS, NCI - Surgery Branch

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 Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

December 1, 2008

Study Completion (Actual)

December 1, 2008

Study Registration Dates

First Submitted

October 19, 2007

First Submitted That Met QC Criteria

October 19, 2007

First Posted (Estimate)

October 22, 2007

Study Record Updates

Last Update Posted (Estimate)

March 16, 2012

Last Update Submitted That Met QC Criteria

March 14, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 070222
  • 07-C-0222
  • CDR0000570181

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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