Clinical trial NCT00547612: Positron Emission Tomography Using [18F]-Labeled Substance P Antagonist Receptor Quantifier in Finding Disease in Patients With Pancreatic Cancer
Official title: Pilot Trial of the NK1 Receptor Radio-Ligand [18F]SPA-RQ: Imaging Pancreatic Ductal Adenocarcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: adenocarcinoma of the pancreas
stage I pancreatic cancer
stage II pancreatic cancer
stage III pancreatic cancer
stage IV pancreatic cancer
recurrent pancreatic cancer
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-10-22
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Proportion of tumors detected by [18F]-labeled substance P antagonist receptor quantifier positron emission tomography
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
state: Maryland
Study officials:
affiliation: NCI - Surgery Branch
name: Richard E. Royal, MD, FACS
role: STUDY_CHAIR
References: