C11 Sodium Acetate PET/CT Imaging of PCa
Primary Purpose
Prostate Cancer
Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Carbon-11 Sodium Acetate
Sponsored by
About this trial
This is an expanded access trial for Prostate Cancer focused on measuring Prostate cancer, diagnostic, imaging, PET/CT, Acetate carbon-11
Eligibility Criteria
Inclusion Criteria:
- Diagnosed prostate cancer
- Able to remain still for duration of each imaging procedure (about 30 minutes)
Exclusion Criteria:
- Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
- Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Sites / Locations
- 200 Medical Plaza, B114
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT02826395
First Posted
July 5, 2016
Last Updated
July 22, 2020
Sponsor
Jonsson Comprehensive Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT02826395
Brief Title
C11 Sodium Acetate PET/CT Imaging of PCa
Official Title
Carbon-11 Sodium Acetate PET/CT Imaging of Prostate Cancer
Study Type
Expanded Access
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
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3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
4. Oversight
5. Study Description
Brief Summary
The investigators propose to conduct Carbon-11 Sodium Acetate PET/CT studies. The purpose of our study is to evaluate the impact of Carbon-11 Sodium Acetate PET/CT studies on patient management in patients with prostate cancer.
Detailed Description
This is an expanded access study under an IND with a total of 300 participants with prostate cancer. Eligible participants will undergo baseline assessments at enrollment. Study participants will receive 11C-Sodium Acetate and will undergo a PET/CT imaging study. All patients referred by Oncologists and Urologists will be screened by a UCLA Nuclear Medicine physician and then accepted for scanning if clinically appropriate. The following steps will take place.
Informed consent will be obtained.
Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded.
Participant will be injected with 20 - 40mCi of 11C-Sodium Acetate intravenously (i.v.).
PET/CT Scans will be performed with or without oral and IV contrast. All investigational scans will be read by at least one board-certified nuclear medicine physician with established expertise in PET/CT of at least 5 years' experience. Fifteen minutes after injection of 11C-Sodium Acetate, the investigators will acquire a scan. Emission images will be acquired for 3-5min/bed position. Intravenous and oral contrast will be given for the CT portion of the study.
Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded following the completion of the scan.
Within 24-48 hours of PET/CT imaging, a follow-up telephone call or email will be conducted to discuss any side effects or reactions to the investigational agent.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Prostate cancer, diagnostic, imaging, PET/CT, Acetate carbon-11
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Carbon-11 Sodium Acetate
Other Intervention Name(s)
C11 Sodium Acetate, C11 Acetate
Intervention Description
PET/CT Scans will be performed with or without oral and IV contrast. All investigational scans will be read by at least one board-certified nuclear medicine physician with established expertise in PET/CT of at least 5 years' experience. Fifteen minutes after injection of 11C-Sodium Acetate, we will acquire a scan Emission images will be acquired for 3-5min/bed position. Intravenous and oral contrast will be given for the CT portion of the study.
10. Eligibility
Sex
Male
Eligibility Criteria
Inclusion Criteria:
Diagnosed prostate cancer
Able to remain still for duration of each imaging procedure (about 30 minutes)
Exclusion Criteria:
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any additional medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study compliance.
Facility Information:
Facility Name
200 Medical Plaza, B114
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21984877
Citation
Czernin J, Benz MR, Allen-Auerbach MS. PET Imaging of Prostate Cancer Using C-Acetate. PET Clin. 2009 Apr;4(2):163-72. doi: 10.1016/j.cpet.2009.05.001. No abstract available.
Results Reference
background
Links:
URL
http://pet.ucla.edu
Description
Related Info
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C11 Sodium Acetate PET/CT Imaging of PCa
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