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History of Changes for Study: NCT01304485
PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
Latest version (submitted March 5, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 February 24, 2011 None (earliest Version on record)
2 February 25, 2011 Outcome Measures and Study Status
3 May 10, 2011 Recruitment Status, Study Status, Conditions, Oversight and Contacts/Locations
4 May 17, 2011 Outcome Measures, Study Description and Study Status
5 November 3, 2011 Sponsor/Collaborators, Study Status and Study Design
6 February 4, 2012 Study Status, Contacts/Locations and Arms and Interventions
7 April 28, 2012 Conditions and Study Status
8 December 1, 2012 Contacts/Locations and Study Status
9 October 9, 2013 Study Status and Study Description
10 June 4, 2014 Study Status
11 January 12, 2015 Study Status
12 February 28, 2015 Contacts/Locations and Study Status
13 March 6, 2015 Study Status and Contacts/Locations
14 April 1, 2016 Study Status and Study Identification
15 September 17, 2016 Study Status, IPDSharing and Study Design
16 February 22, 2017 Study Status
17 March 5, 2019 Recruitment Status, Study Status, Contacts/Locations and Study Design
Comparison Format:

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Study NCT01304485
Submitted Date:  February 24, 2011 (v1)

Open or close this module Study Identification
Unique Protocol ID: AMIC-AC-001
Brief Title: PET Imaging Characteristics of C11-Acetate in Patients With Recurrent Prostate Carcinoma
Official Title: Phase 2 Study: PET Imaging Characteristics of C11-Acetate in Patients With Prostate Carcinoma, Detection of Recurrent Disease With PSA Relapse
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2011
Overall Status: Not yet recruiting
Study Start: April 2011
Primary Completion: April 2013 [Anticipated]
Study Completion: April 2013 [Anticipated]
First Submitted: February 24, 2011
First Submitted that
Met QC Criteria:
February 24, 2011
First Posted: February 25, 2011 [Estimate]
Last Update Submitted that
Met QC Criteria:
February 24, 2011
Last Update Posted: February 25, 2011 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Phoenix Molecular Imaging
Responsible Party:
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
Brief Summary: Positron emission tomography (PET) imaging evaluation in men with recurrent prostate cancer to select patients who may benefit from directed therapy
Detailed Description:

The goal of this project is improved imaging of prostate cancer by positron emission tomography (PET) with use of the radiopharmaceutical C-11 Acetate, utilizing state-of-the-art PET/CT camera technology and processing algorithms.

A successful effort will lead to more accurate diagnosis of recurrence in patients with prostate cancer to allow for early directed therapy. This study is designed to generate data to add to the understanding of the effectiveness of C-11 Acetate, focusing on patients with recurrent or persistent disease after prostatectomy or radiation therapy.

Open or close this module Conditions
Conditions: Prostatic Neoplasms
Keywords: Prostate carcinoma sodium aceate c11 recurrent PET
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Diagnostic
Study Phase: Phase 2
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 200 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Sodium Acetate C11 PET Imaging Drug: Sodium Acetate C11
PET Imaging with Sodium Acetate C11
Other Names:
  • Carbon 11 Acetate PET
Open or close this module Outcome Measures
Primary Outcome Measures:
1. SUV (Standardized Uptake Value)
[ Time Frame: Assessed at time of PET imaging - i.e. at the time of primary investigation/PET agent administration ]

Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest.
Secondary Outcome Measures:
1. PSA (prostate specific antigen)
[ Time Frame: Every 3months for 24 months after PET imaging ]

PSA will be monitored per routine clinical follow-up.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: Male
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

Inclusion Criteria:

  • recurrent prostate cancer (detectable PSA following radical prostatectomy or rising PSA in patients with radiation therapy as the primary treatment)

Exclusion Criteria:

  • < 18 years old
  • claustrophobic patients
Open or close this module Contacts/Locations
Central Contact Person: Fabio Almeida, MD
Telephone: 602.331.1771
Email: falmeida@cereusmed.com
Central Contact Backup: Carlos Patino, CNMT
Telephone: 520.321.4057
Email: cpatino@healthwestpartners.net
Study Officials: Fabio Almeida, M.D.
Principal Investigator
Medical Director, Arizona Molecular Imaging Center
Locations: United States, Arizona
Arizona Molecular Imaging Center
Phoenix, Arizona, United States, 85040
Contact:Principal Investigator: Fabio Almeida, MD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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