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

Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547612
• Other study ID #: 070222
• Secondary ID: 07-C-0222CDR0000
• Status: Completed
• Phase: Phase 1
• First received: October 19, 2007
• Last updated: March 14, 2012
• Start date: September 2007
• Est. completion date: December 2008

Study information

• Verified date: March 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Other:
• high performance liquid chromatography

• pharmacological study

Radiation:
• [18F]-labeled substance P antagonist receptor quantifier

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography			No