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
This is a prospective non-blinded case series involving the acquisition of a pair production PET/CT as soon as possible after an already performed Y-90 Sirspheres treatment of hepatic malignancy. It will be performed in addition to the standard Brehmsstrahlung SPECT scan. The sequence of the two scans in each case (PET/CT vs SPECT) will be determined by availability of the scanners at the time. However, it is intended that both be acquired on the day of the Y-90 treatment.
The length of subject participation will be one year.
The measures used will be mostly qualitative in nature, and will include:
- Correlation with expected vs. achieved tumor coverage by the treatment
- Correlation between treatment distribution depicted by Brehmsstrahlung scans vs. the Internal Pair Production PET/CT scans, to.
- Detection of non-target embolization, where applicable, and qualitative comparison between the two modalities as to the conspicuity of the abnormality
Qualitative methods will be used by the analysis of the obtained PET/CT images and comparing them to the Brehmsstrahlung SPECT images as previously described.
|Condition or disease||Intervention/treatment||Phase|
|Liver Cancer Hepatic Tumors||Device: PET/CT Scan||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Follow-up Yttrium-90 Internal Pair Production PET/CT Imaging in Patients With Primary or Metastatic Liver Tumors as Compared With Brehmsstrahlung Imaging: A Prospective Case Series|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||October 2016|
|Actual Study Completion Date :||October 2016|
|Experimental: Y90 Based PET/CT Scan||
Device: 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. [ Time Frame: 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.
- Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans. [ Time Frame: 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.
- Comparison of Y-90 PET/CT to Y90 SPECT [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202317
|United States, Florida|
|Jackson Health System|
|Miami, Florida, United States, 33136|
|Principal Investigator:||Jason Salsamendi, MD||University of Miami|