Prostate CancerNCT02826395
C11 Sodium Acetate PET/CT Imaging of PCa
A study testing Carbon-11 Sodium Acetate in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Carbon-11 Sodium Acetate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Child, Adult, Older adult
Who may be able to join
- Diagnosed prostate cancer
- Able to remain still for duration of each imaging procedure (about 30 minutes)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
200 Medical Plaza, B114
Los Angeles, California, 90095
About this study
Official title: Carbon-11 Sodium Acetate PET/CT Imaging of Prostate Cancer
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- Carbon-11 Sodium Acetate
- Keywords
- Prostate cancer, diagnostic, imaging, PET/CT, Acetate carbon-11
- Medical subject headings
- Prostatic Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon-11 Sodium AcetateDrug
Also called C11 Sodium Acetate, C11 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826395
- Sponsor's protocol ID
- ACETATE16-000260EA
- Other IDs
- 16-000260
- Status last verified
- Jan 2019
- First submitted
- 5 Jul 2016
- Last updated
- 24 Jul 2020
- Results posted
- No
Publications
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.
PubMed 21984877
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon-11 Sodium Acetate PET/CT Imaging of Prostate Cancer
- ClinicalTrials.gov ID
- NCT02826395
- Acronym / sponsor ID
- ACETATE16-000260EA
- Conditions
- Prostate Cancer
- Keywords
- Prostate cancer, diagnostic, imaging, PET/CT, Acetate carbon-11
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- First posted
- 11 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosed prostate cancer
- Able to remain still for duration of each imaging procedure (about 30 minutes)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbon-11 Sodium AcetateAlso: C11 Sodium Acetate, C11 AcetatePET/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. | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2020.
- Background: PubMed 21984877Czernin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbon-11 Sodium Acetate in people with Prostate Cancer, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02826395, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2020.