11C Acetate Imaging Post Prostatectomy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01602783|
Recruitment Status : Terminated (Slow accrual; no further funding)
First Posted : May 21, 2012
Last Update Posted : March 18, 2014
This research is being conducted to test an imaging technique that may be able to detect small amounts of prostate cancer that can not be detected by standard imaging.
Many patients who are diagnosed with prostate cancer undergo surgery to remove the prostate. After this surgery, some patients have a PSA blood test that reveals a low but detectable level of PSA. This PSA may be produced by cancer cells in one of two locations: (1) near the area where the prostate used to be, or (2) elsewhere in the body. If the cancer is only in the area where the prostate used to be, it can be successfully treated with radiation to that area. If the cancer is elsewhere, radiation is not helpful. Currently, there is no available scan that can detect cancer when the PSA is still so low.
The test used in this study is called [11C] acetate PET screening. [11C] acetate is a radioactive tracer that is given by vein to patients before PET scanning. The PET scanner then detects radioactivity from the tracer that is attached to cells within your body and uses this information to create images (pictures) on a computer screen.
[11C] acetate PET scanning has been shown in early studies to detect smaller amounts of prostate cancer that can be detected by standard imaging tests such as CT scan and bone scan. If it is successful at detecting very small amounts of prostate cancer, [11C] acetate PET scanning will help doctors identify patients who will benefit from radiation therapy after their prostate has been surgically removed. It will also help them identify patients who have small amounts of prostate cancer in other parts of the body and will not benefit from radiation to the prostate area.
This type of PET scan is investigational. "Investigational" means that the scan is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not approved this type of PET scan for your type of cancer. The information collected by this scan will determine whether this type of scanning is helpful but it will not be used to make decisions about your medical care.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: 11C Acetate Imaging||Not Applicable|
If you decide to participate in the study and are eligible, you will undergo a single [11C] acetate PET scan. This scan is designed to detect small amounts of your tumor that were not detected by the CT scan or the bone scan. On the day of the scan, you will fast for at least four hours prior to being given the tracer injection by vein. You will then be scanned in the PET scanner. The entire procedure will take approximately 2 hours.
The investigators would like to keep track of your medical condition after you have completed your scan. The investigators would like to do this by looking up information in your medical record during the year following the scan to see how you are doing. Checking your condition helps us understand whether the [11C] acetate PET scan will be helpful to other patients in the future.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of 11C Acetate Imaging for Improved Prediction of the Effectiveness of Salvage Pelvic Radiation Post Prostatectomy: A Pilot Study|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||February 2014|
|Actual Study Completion Date :||February 2014|
Experimental: 11C Acetate Imaging
11C acetate imaging
Other: 11C Acetate Imaging
- Sensitivity of 11C Acetate PET [ Time Frame: 1 year ]Preliminarily demonstrate that the 11C acetate PET imaging of subjects who have experienced PSA relapse after prostatectomy for prostate cancer is more sensitive than currently available imaging techniques. Enrolled participants will have no evidence of recurrent disease on gold-standard imaging with CT abdomen/pelvis and 99mTc MDP bone scan (approximate sensitivity of 0%). The primary outcome is evidence of residual/recurrent disease as demonstrated by 11C acetate PET uptake outside of the prostatectomy bed.
- Establish a Preliminary Institutional Experience with 11C Acetate Imaging [ Time Frame: 1 year ]To establish a preliminary institutional experience with 11C acetate imaging of men with prostate cancer
- Correlate 11C Acetate PET Imaging Findings with PSA Evidence of Response [ Time Frame: 1 year ]To descriptively correlate 11C acetate PET imaging findings with PSA evidence of response to subsequent salvage radiation therapy at 3 months and 6 months after the conclusion of radiation
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01602783
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Umar Mahmood, MD, PhD||Massachusetts General Hospital|