Positron Emission Tomography Using [18F]-Labeled Substanc... | NCT00547612

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

NCT00547612

Sponsor

National Institutes of Health Clinical Center (CC)

Status

Completed

Last Update Posted

Mar 16, 2012Estimated

Enrollment

33Estimated

Phase

Phase 1

Conditions

Pancreatic Cancer

Interventions

high performance liquid chromatography
pharmacological study
[18F]-labeled substance P antagonist receptor quantifier

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Sep 2007

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Oct 19, 2007

First Submission Date that Met QC Criteria

Oct 19, 2007

First Posted Date

Oct 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2012

Last Update Posted Date

Mar 16, 2012Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Estimated

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms
D004066	Digestive System Diseases
D010182	Pancreatic Diseases
D004700	Endocrine System Diseases

ID	Term
D002853	Chromatography, Liquid
D002845	Chromatography
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques

Name	Type	Description	Arm Group Labels	Other Names
high performance liquid chromatography	Other
pharmacological study	Other
[18F]-labeled substance P antagonist receptor quantifier	Radiation

ID	Type	Description	Link
07-C-0222
CDR0000570181