Follow-up Yttrium-90 Internal Pair Production PET/CT Imaging in Patients With Primary or Metastatic Liver Tumors as Compared With Brehmsstrahlung Imaging
Conditions
Liver Cancer - Hepatic Tumors
Conditions: official terms
Liver Neoplasms
Conditions: Keywords
Liver Cancer, Hepatic Tumors, Primary Liver Tumors, Metastastic Liver Tumors, Yttrium-90, Y-90
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Intervention
Name: PET/CT Scan
Type: Device
Overall Status
Recruiting
Summary
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 Brehmsstralung 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:

- Degree of correlation with expected vs. achieved tumor coverage by the treatment

- Degree of correlation between treatment distribution depicted by Brehmsstrahlung scans vs. the Internal Pair Production PET/CT scans, to include an assessment/comparison of the precision of anatomic localization achieved by the two modalities.

- Determination of Tumor/Background ratios, and correlating with planned dose

- 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 Brehmsstralung SPECT images as previously described.

Tumor to background ratios will be generated and used as a metric for correlation with planned/administered dose and also with CT and/or FDG PET scans pre or post treatment, if available. For CT, the RECIST criteria will be used to calculate volumes of necrosis, would be used for the correlation. For FDG PET scans, SUV would be used for correlation.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Recipient of Selective Internal Radiation Treatment within 5 days.

- Anticipated ability to remain still for up to 40 minutes

Exclusion Criteria:

- Anticipated Inability to lie still for up to 40 minutes

- Severe claustrophobia

- Significant cardiovascular instability, or instability of other medical/surgical conditions, such that it would be deemed unsafe or technically not feasible to obtain a PET/CT, as determined by the any member of the investigative team

- Failed deployment of the planned Y-90 treatment for any reason

- Duration of time longer than 5 days since administration of the Y-90 treatment

- Age <18

- Known pregnancy
Location
Jackson Health System
Miami, Florida, United States
Status: Recruiting
Contact: Jason Salsamendi, MD - 305-585-8339 - JSalsamendi@med.miami.edu
Start Date
April 2013
Sponsors
University of Miami
Source
University of Miami
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page