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Anti-3-[18F]FACBC Imaging of Parathyroid Adenomas

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ClinicalTrials.gov Identifier: NCT01574287
Recruitment Status : Completed
First Posted : April 10, 2012
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
David M. Schuster, MD, Emory University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Parathyroid Disease
Intervention Drug: FACBC
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FACBC
Hide Arm/Group Description FACBC: Drug is give intravenously over 2 minutes at time of scan
Period Title: Overall Study
Started 4
Completed 4
Not Completed 0
Arm/Group Title FACBC
Hide Arm/Group Description FACBC: Drug is give intravenously over 2 minutes at time of scan
Overall Number of Baseline Participants 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants
57  (9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
Female
3
  75.0%
Male
1
  25.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
4
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 4 participants
4
1.Primary Outcome
Title Detection Rate of Parathyroid Adenomas of Anti-3-[18F]FACBC Modality
Hide Description Detection rate of parathyroid adenomas using anti-3-[18F]FACBC modality is assessed by comparing [18F]FACBC and surgical findings.
Time Frame At approximately 1 month post scan (time of surgery and pathologic analysis)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FACBC
Hide Arm/Group Description:
FACBC: Drug is give intravenously over 2 minutes at time of scan
Overall Number of Participants Analyzed 4
Measure Type: Number
Unit of Measure: percentage of adenomas detected
80
2.Secondary Outcome
Title Target-to-background Ratio (TBR) of Anti-3-[18F]FACBC for Blood Pool
Hide Description To evaluate uptake mechanisms of anti-3-[18F]FACBC, target-to-background ratio (TBR) of anti-3-[18F]FACBC is assessed
Time Frame 5-10 min after intravenous bolus injection of [18F]fluciclovine
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title FACBC
Hide Arm/Group Description:
FACBC: Drug is give intravenously over 2 minutes at time of scan
Overall Number of Participants Analyzed 4
Mean (Standard Deviation)
Unit of Measure: SUVmax
1.3  (0.6)
Time Frame 1 month
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FACBC
Hide Arm/Group Description FACBC: Drug is give intravenously over 2 minutes at time of scan
All-Cause Mortality
FACBC
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Serious Adverse Events
FACBC
Affected / at Risk (%)
Total   0/4 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
FACBC
Affected / at Risk (%)
Total   0/4 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Schuster, David
Organization: Emory University
Phone: 404-712-4859
EMail: dschust@emory.edu
Layout table for additonal information
Responsible Party: David M. Schuster, MD, Emory University
ClinicalTrials.gov Identifier: NCT01574287    
Other Study ID Numbers: IRB00051415
First Submitted: March 31, 2012
First Posted: April 10, 2012
Results First Submitted: June 14, 2019
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019