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

Sponsors

Lead Sponsor: National Institutes of Health Clinical Center (CC)

Collaborator: National Cancer Institute (NCI)

Source National Institutes of Health Clinical Center (CC)
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.

Overall Status Completed
Start Date 2007-09-01
Completion Date 2008-12-01
Primary Completion Date 2008-12-01
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography
Enrollment 33
Condition
Intervention

Intervention Type: Other

Intervention Name: high performance liquid chromatography

Intervention Type: Other

Intervention Name: pharmacological study

Intervention Type: Radiation

Intervention Name: [18F]-labeled substance P antagonist receptor quantifier

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Richard E. Royal, MD, FACS Study Chair NCI - Surgery Branch
Location
Facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Location Countries

United States

Verification Date

2012-03-01

Keywords
Condition Browse
Study Design Info

Allocation: Non-Randomized

Primary Purpose: Diagnostic

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