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


Phase 1
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Primary Purpose: Diagnostic

Outcome Measure:

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

Safety Issue:

No

Principal Investigator

Richard E. Royal, MD, FACS

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch

Authority:

United States: Food and Drug Administration

Study ID:

070222

NCT ID:

NCT00547612

Start Date:

September 2007

Completion Date:

December 2008

Related Keywords:

  • Pancreatic Cancer
  • adenocarcinoma of the pancreas
  • stage I pancreatic cancer
  • stage II pancreatic cancer
  • stage III pancreatic cancer
  • stage IV pancreatic cancer
  • recurrent pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral OfficeBethesda, Maryland  20892-1182