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Completed

NCT Number: NCT00547612

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

high performance liquid chromatography

Other

pharmacological study

Other

[18F]-labeled substance P antagonist receptor quantifier

Radiation

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

National Institutes of Health Clinical Center (CC)

Nih

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Oct 22, 2007
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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