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

Sponsored by:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00547612

Purpose

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.

Condition	Intervention	Phase
Pancreatic Cancer	Other: high performance liquid chromatography Other: pharmacological study Radiation: [18F]-labeled substance P antagonist receptor quantifier	Phase I

MedlinePlus related topics: Cancer Pancreatic Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Uncontrolled
Official Title:	Pilot Trial of the NK1 Receptor Radio-Ligand [18F]SPA-RQ: Imaging Pancreatic Ductal Adenocarcinoma

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography [ Designated as safety issue: No ]

Estimated Enrollment:	33
Study Start Date:	September 2007
Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00547612

Locations

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States, 20892-1182

Sponsors and Collaborators

National Cancer Institute (NCI)

Investigators

Study Chair:

Richard E. Royal, MD, FACS

NCI - Surgery Branch

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000570181, NCI-07-C-0222
Study First Received:	October 19, 2007
Last Updated:	February 7, 2009
ClinicalTrials.gov Identifier:	NCT00547612 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer

stage III pancreatic cancer
stage IV pancreatic cancer
recurrent pancreatic cancer

Study placed in the following topic categories:

Neurotransmitter Agents
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases
Pancrelipase
Substance P
Recurrence
Signs and Symptoms

Digestive System Diseases
Gastrointestinal Neoplasms
Pancreatic Diseases
Carcinoma, Ductal, Breast
Endocrinopathy
Adenocarcinoma
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Neurotransmitter Agents
Digestive System Neoplasms
Molecular Mechanisms of Pharmacological Action
Pancreatic Neoplasms
Physiological Effects of Drugs
Endocrine System Diseases
Substance P

Pharmacologic Actions
Neoplasms
Neoplasms by Site
Digestive System Diseases
Pancreatic Diseases
Endocrine Gland Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009