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Follow-up Yttrium-90 Internal Pair Production PET/CT vs Brehmsstrahlung Imaging in Patients With Primary/Metastatic Liver Tumors

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ClinicalTrials.gov Identifier: NCT02202317
Recruitment Status : Completed
First Posted : July 29, 2014
Results First Posted : December 29, 2017
Last Update Posted : December 29, 2017
Sponsor:
Information provided by (Responsible Party):
Jason Salsamendi, University of Miami

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Screening
Conditions Liver Cancer
Hepatic Tumors
Intervention Device: PET/CT Scan
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Y90 Based PET/CT Scan
Hide Arm/Group Description PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
Period Title: Overall Study
Started 9
Completed 8
Not Completed 1
Reason Not Completed
Lost to Follow-up             1
Arm/Group Title Y90 Based PET/CT Scan
Hide Arm/Group Description PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
The initial number of patients that participated in the study is 9. However, one patient elected not to return for the PET/CT scan after Y-90 delivery, therefore the total number of participants analyzed is 8 patients.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
4
  50.0%
>=65 years
4
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
1.Primary Outcome
Title Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization.
Hide Description Number of participants with detected extrahepatic non-target embolization. A qualitative comparison between the two modalities (Y-90 PET/CT and Brehmsstrahlung SPECT) as to the conspicuity of the abnormality would have been conducted had any participant had that result.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Y90 Based PET/CT Scan
Hide Arm/Group Description:
PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
2.Secondary Outcome
Title Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans.
Hide Description Number of participants demonstrating a similar treatment distribution depicted by Tc99mMAA(Technetium-99m macroaggregated albumin) Brehmsstrahlung scans vs. achieved Y-90 distribution on the Internal Pair Production PET/CT scans.
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Y90 Based PET/CT Scan
Hide Arm/Group Description:
PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
3.Secondary Outcome
Title Comparison of Y-90 PET/CT to Y90 SPECT
Hide Description Number of participants with a similar Y90 distribution depicted on Post Y90 delivery PET/CT and SPECT modalities, specifically comparing Y90 distribution within the treated tumors.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Y90 Based PET/CT Scan
Hide Arm/Group Description:
PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
8
 100.0%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Y90 Based PET/CT Scan
Hide Arm/Group Description PET/CT Scan: Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
All-Cause Mortality
Y90 Based PET/CT Scan
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Y90 Based PET/CT Scan
Affected / at Risk (%)
Total   0/8 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Y90 Based PET/CT Scan
Affected / at Risk (%)
Total   0/8 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Jason Salsamendi
Organization: University of Miami Miller School of Medicine
Phone: 305-585-7500
EMail: jsalsamendi@miami.edu
Layout table for additonal information
Responsible Party: Jason Salsamendi, University of Miami
ClinicalTrials.gov Identifier: NCT02202317    
Other Study ID Numbers: 20120092
First Submitted: July 24, 2014
First Posted: July 29, 2014
Results First Submitted: November 1, 2017
Results First Posted: December 29, 2017
Last Update Posted: December 29, 2017