C11 Sodium Acetate PET/CT Imaging of PCa

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: No longer available

Administrative data

• NCT number: NCT02826395
• Other study ID #: ACETATE16-000260EA
• Secondary ID: 16-000260
• Status: No longer available

Study information

• Verified date: January 2019
• Source: Jonsson Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: No longer available
• Enrollment: 0
• Gender: Male
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• Carbon-11 Sodium Acetate
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.

Locations

Country	Name	City	State
United States	200 Medical Plaza, B114	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Jonsson Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

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