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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00547612
First received: October 19, 2007
Last updated: March 14, 2012
Last verified: March 2012

October 19, 2007
March 14, 2012
September 2007
December 2008   (final data collection date for primary outcome measure)
Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography [ Designated as safety issue: No ]
Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography
Complete list of historical versions of study NCT00547612 on ClinicalTrials.gov Archive Site
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Positron Emission Tomography Using [18F]-Labeled Substance P Antagonist Receptor Quantifier in Finding Disease in Patients With Pancreatic Cancer
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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Primary Purpose: Diagnostic
Pancreatic Cancer
  • Other: high performance liquid chromatography
  • Other: pharmacological study
  • Radiation: [18F]-labeled substance P antagonist receptor quantifier
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
33
December 2008
December 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547612
070222, 07-C-0222, CDR0000570181
Not Provided
Not Provided
National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Study Chair: Richard E. Royal, MD, FACS NCI - Surgery Branch
National Institutes of Health Clinical Center (CC)
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP