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

NCT ID: NCT02202317

Last Updated: 2017-12-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Cancer Hepatic Tumors

Keywords

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Liver Cancer Hepatic Tumors Primary Liver Tumors Metastatic Liver Tumors Yttrium-90 Y-90

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Y90 Based PET/CT Scan

Group Type EXPERIMENTAL

PET/CT Scan

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Jason Salsamendi

Associate Professor of Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Salsamendi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Jackson Health System

Miami, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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20120092

Identifier Type: -

Identifier Source: org_study_id