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

NCT02202317 | Completed Results

• 1 other identifier: 20120092
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Hepatic Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

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

  12 months

• Comparison of Y-90 PET/CT to Y90 SPECT

  12 Months

Study Arms (1)

Y90 Based PET/CT Scan

EXPERIMENTAL

Device: PET/CT Scan

Interventions

PET/CT Scan 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.

Y90 Based PET/CT Scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

Jackson Health System

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Interventions

Positron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Positron-Emission Tomography; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Results Point of Contact

• Title: Dr Jason Salsamendi
• Organization: University of Miami Miller School of Medicine

jsalsamendi@miami.edu

305-585-7500

Study Officials

• Jason Salsamendi, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Clinical

Study Record Dates

• First Submitted: July 24, 2014
• First Posted: July 29, 2014
• Study Start: April 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 29, 2017
• Results First Posted: December 29, 2017

Record last verified: 2017-12

Locations

US (1)