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

Liver Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02202317
• Other study ID #: 20120092
• Status: Completed
• Phase: N/A
• First received: July 24, 2014
• Last updated: December 27, 2017
• Start date: April 2013
• Est. completion date: October 2016

Study information

• Verified date: December 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatic Tumors
• Liver Cancer
• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	Jackson Health System	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	12 months
Secondary	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.	12 Months