Trial Outcomes & Findings for Follow-up Yttrium-90 Internal Pair Production PET/CT vs Brehmsstrahlung Imaging in Patients With Primary/Metastatic Liver Tumors (NCT NCT02202317)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

9 participants

Primary outcome timeframe

12 months

Results posted on

2017-12-29

Participant Flow

Participant milestones

Participant milestones
Measure	Y90 Based PET/CT Scan 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 Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Y90 Based PET/CT Scan 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 Study Lost to Follow-up	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Y90 Based PET/CT Scan n=8 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Y90 Based PET/CT Scan n=8 Participants 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.
Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization.	0 Participants

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Outcome measures
Measure	Y90 Based PET/CT Scan n=8 Participants 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.
Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans.	8 Participants

SECONDARY outcome

Timeframe: 12 Months

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.

Outcome measures

Outcome measures
Measure	Y90 Based PET/CT Scan n=8 Participants 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.
Comparison of Y-90 PET/CT to Y90 SPECT	8 Participants

Adverse Events

Y90 Based PET/CT Scan

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Jason Salsamendi

University of Miami Miller School of Medicine

Phone: 305-585-7500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place