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

Not Applicable

Completed

• Conditions: Hepatic Tumors; Liver Cancer
• Interventions: Device: PET/CT Scan

• Registration Number: NCT02202317
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-07-24
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-29
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Results First Submitted: 2017-11-01
• Status Verified: 2017-12
• Results First Submitted QC: 2017-12-27
• Last Update Submitted: 2017-12-27
• Results First Posted: 2017-12-29
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

• Recipient of Selective Internal Radiation Treatment within 5 days.
• Anticipated ability to remain still for up to 40 minutes

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Y90 Based PET/CT Scan	PET/CT Scan	-

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Jackson Health System; 🇺🇸 Miami, Florida, United States