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

• 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: University of Miami
• 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

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Y90 Based PET/CT Scan
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

Baseline Characteristics

Arm/Group Title		Y90 Based PET/CT Scan
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
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%

Outcome Measures

1. Primary Outcome

Title	Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Y90 Based PET/CT Scan
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.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Y90 Based PET/CT Scan
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
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Y90 Based PET/CT Scan
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%

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Y90 Based PET/CT Scan
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	--/--
Serious Adverse Events
	Y90 Based PET/CT Scan
	Affected / at Risk (%)
Total	0/8 (0.00%)
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%)

Limitations and Caveats

[Not Specified]

More Information

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

• Name/Title: Dr Jason Salsamendi
• Organization: University of Miami Miller School of Medicine
• Phone: 305-585-7500
• EMail: jsalsamendi@miami.edu

• 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