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Clinical Trials/NCT02826395
NCT02826395
No Longer Available
Not Applicable

Carbon-11 Sodium Acetate PET/CT Imaging of Prostate Cancer

Jonsson Comprehensive Cancer Center1 site in 1 countryJuly 11, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Jonsson Comprehensive Cancer Center
Locations
1
Status
No Longer Available
Last Updated
5 years ago

Overview

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. 1. Informed consent will be obtained. 2. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded. 3. Participant will be injected with 20 - 40mCi of 11C-Sodium Acetate intravenously (i.v.). 4. 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. 5. Vital signs (heart rate, blood pressure, respiratory rate, pulse oxymetry) will be recorded following the completion of the scan. 6. 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.

Registry
clinicaltrials.gov
Start Date
July 11, 2016
End Date
TBD
Last Updated
5 years ago
Study Type
Expanded Access
Sex
Male

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Not specified

Study Sites (1)

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