Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-03-26 @ 8:34 AM
Study NCT ID:
NCT01777061
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2018-05-16
First Post:
2013-01-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Management Decisions for Recurrent Prostate Cancer Patients Based on [11C]Acetate PET Scan
Sponsor:
Wendell Yap, MD
Organization:
Study Overview
Official Title:
Clinical Management Decisions Based on [11C]Acetate Positron Emission Tomography Performed on Prostate Cancer Patients With Biochemical Recurrence
Status:
NO_LONGER_AVAILABLE
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
When evaluating prostate cancer patients for recurrent disease, computed tomography (CT), and magnetic resonance imaging (MRI) are both highly sensitive methods for detecting lymph nodes, but are not specific as to whether the lymph nodes are malignant or benign.
While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer.
This study will assess the clinical effectiveness of utilizing \[11C\]Acetate PET scans in identifying recurrent prostate cancer.
While positron emission tomography (PET) utilizing radioactive glucose (FDG) has revolutionized staging, restaging, and monitoring response to therapy in many prevalent cancers such as breast, colorectal, esophageal, head and neck, lung, lymphoma, and melanoma, findings with prostate cancer have proven less sensitive because prostate cancer has a lower avidity for glucose. A newer PET isotope, utilizing acetate that is incorporated into the cell membrane of rapidly proliferating cells, has shown greater sensitivity than FDG in detecting prostate cancer.
This study will assess the clinical effectiveness of utilizing \[11C\]Acetate PET scans in identifying recurrent prostate cancer.
Detailed Description:
FDG-PET imaging uses a form of radioactive glucose (18-fluoro-deoxyglucose or FDG), which allows the measurement of glucose metabolic rate of any tissue in the body. The most prevalent tumors have a glucose avidity that is typically greater than 2.5 times the avidity of benign tissue. Therefore, FDG-PET is able to discriminate between benign lymph nodes and those containing metastases, and similarly between scar tissue and recurrence of tumor.
Unfortunately, prostate cancer is only minimally glucose avid, and therefore, FDG-PET is much less effective in staging prostate cancer. The current FDA-approved imaging agent for prostate cancer is a monoclonal antibody specific for prostate cancer cells, capromab pendetide, labeled with a long-lived radionuclide \[111\]Indium that is used to image the patient over a six day period. However, recent data show that another PET radiopharmaceutical, \[11C\]Acetate (which has been FDA approved for years for cardiac imaging), is avidly taken up by prostate metastasis and is more sensitive than either \[111\]Indium capromab pendetide or FDG-PET.
This study will assess the clinical effectiveness of utilizing \[11C\]Acetate PET scans in identifying recurrent prostate cancer and aim to find at what PSA levels it is most effective.
Unfortunately, prostate cancer is only minimally glucose avid, and therefore, FDG-PET is much less effective in staging prostate cancer. The current FDA-approved imaging agent for prostate cancer is a monoclonal antibody specific for prostate cancer cells, capromab pendetide, labeled with a long-lived radionuclide \[111\]Indium that is used to image the patient over a six day period. However, recent data show that another PET radiopharmaceutical, \[11C\]Acetate (which has been FDA approved for years for cardiac imaging), is avidly taken up by prostate metastasis and is more sensitive than either \[111\]Indium capromab pendetide or FDG-PET.
This study will assess the clinical effectiveness of utilizing \[11C\]Acetate PET scans in identifying recurrent prostate cancer and aim to find at what PSA levels it is most effective.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: