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

Primary Purpose

Liver Cancer, Hepatic Tumors

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PET/CT Scan
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Liver Cancer focused on measuring Liver Cancer, Hepatic Tumors, Primary Liver Tumors, Metastatic Liver Tumors, Yttrium-90, Y-90

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jackson Health System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Y90 Based PET/CT Scan

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans.
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
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.

Full Information

First Posted
July 24, 2014
Last Updated
December 27, 2017
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT02202317
Brief Title
Follow-up Yttrium-90 Internal Pair Production PET/CT vs Brehmsstrahlung Imaging in Patients With Primary/Metastatic Liver Tumors
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 Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Hepatic Tumors
Keywords
Liver Cancer, Hepatic Tumors, Primary Liver Tumors, Metastatic Liver Tumors, Yttrium-90, Y-90

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Y90 Based PET/CT Scan
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PET/CT Scan
Intervention Description
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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason Salsamendi, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jackson Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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