Study Evaluating the Correlation Between C-11 Acetate Upt... | NCT00139191

Studies
Study Evaluating the Correlation Between C-11 Acetate Uptake and Retention as Measured by PET and FAS in Prostate Cancer

NCT00139191

Sponsor

Dana-Farber Cancer Institute

Status

Completed

Last Update Posted

Nov 2, 2009Estimated

Enrollment

Phase

Not Applicable

Conditions

Prostate Cancer

Interventions

C-11 acetate PET scan

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

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

May 2006Actual

First Submitted Date

Aug 29, 2005

First Submission Date that Met QC Criteria

Aug 29, 2005

First Posted Date

Aug 31, 2005Estimated

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

Oct 30, 2009

Last Update Posted Date

Nov 2, 2009Estimated

Name	Class
Beth Israel Deaconess Medical Center	OTHER
Massachusetts General Hospital	OTHER

Description Module

Brief Summary

The purpose of this study is to understand if a new type of radiology test called positron emission tomography (PET) with carbon 11 acetate will help us to understand which cancers produce more of a protein called fatty acid synthase (FAS).

Detailed Description

Within 4 weeks of the patient's scheduled surgery they will undergo a C11 acetate PET scan. This scan will be performed at the Massachusetts General Hospital's Nuclear Medicine Department and involves an intravenous injection of acetate with a radioactive tracer followed by a PET scan. The scan will determine how well the tumor is taking up the acetate.
Patients will also undergo a CT scan of the pelvis at the same time as the PET scan.
After surgery, the removed tumor will have additional testing that will look at different factors that may tell us how aggressive the tumor is and how much FAS is within the tumor. FAS seems to be produced in higher amounts by prostate cancer cells than normal cells. We will then try to determine if the results of the C11 acetate PET scan can tell us how much FAS is produced by prostate cancer cells.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
C-11 acetate PET scan	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To explore the associations between measures of C-11 acetate uptake and retention into prostate tumors and levels of FAS expression in tissue.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Histologically documented prostate cancer
Planned radical prostatectomy
> 50% cores positive for prostate cancer from prostate biopsy or a palpable prostate nodule
Older than 18 years of age

Exclusion Criteria:

Inability to lay on a scanner for 60 minutes

Accepts Healthy Volunteers

Sex

Male

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robert Ross, MD	Dana-Farber Cancer Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Massachusetts General Hospital		Boston	Massachusetts	02114	United States
Beth Israel Deaconess Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D011471	Prostatic Neoplasms

Ancestor Terms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided