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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
Sponsor:
Information provided by (Responsible Party):
Jason Salsamendi, 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.


Condition or disease Intervention/treatment Phase
Liver Cancer Hepatic Tumors Device: PET/CT Scan Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
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

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, Florida
Jackson Health System
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Jason Salsamendi, MD University of Miami

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Responsible Party: Jason Salsamendi, Associate Professor of Clinical, University of Miami
ClinicalTrials.gov Identifier: NCT02202317     History of Changes
Other Study ID Numbers: 20120092
First Posted: July 29, 2014    Key Record Dates
Results First Posted: December 29, 2017
Last Update Posted: December 29, 2017
Last Verified: December 2017

Keywords provided by Jason Salsamendi, University of Miami:
Liver Cancer
Hepatic Tumors
Primary Liver Tumors
Metastatic Liver Tumors
Yttrium-90
Y-90

Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases