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

Primary Purpose

Pancreatic Cancer

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
high performance liquid chromatography
pharmacological study
[18F]-labeled substance P antagonist receptor quantifier
Sponsored by
National Institutes of Health Clinical Center (CC)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, recurrent pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
October 19, 2007
Last Updated
March 14, 2012
Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00547612
Brief Title
Positron Emission Tomography Using [18F]-Labeled Substance P Antagonist Receptor Quantifier in Finding Disease in Patients With Pancreatic Cancer
Official Title
Pilot Trial of the NK1 Receptor Radio-Ligand [18F]SPA-RQ: Imaging Pancreatic Ductal Adenocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institutes of Health Clinical Center (CC)
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer
Keywords
adenocarcinoma of the pancreas, stage I pancreatic cancer, stage II pancreatic cancer, stage III pancreatic cancer, stage IV pancreatic cancer, recurrent pancreatic cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Allocation
Non-Randomized
Enrollment
33 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
high performance liquid chromatography
Intervention Type
Other
Intervention Name(s)
pharmacological study
Intervention Type
Radiation
Intervention Name(s)
[18F]-labeled substance P antagonist receptor quantifier
Primary Outcome Measure Information:
Title
Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard E. Royal, MD, FACS
Organizational Affiliation
NCI - Surgery Branch
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

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

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