Clinical trial NCT02202317: Follow-up Yttrium-90 Internal Pair Production PET/CT vs Brehmsstrahlung Imaging in Patients With Primary/Metastatic Liver Tumors
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Cancer
Hepatic Tumors
Keywords: Liver Cancer
Hepatic Tumors
Primary Liver Tumors
Metastatic Liver Tumors
Yttrium-90
Y-90
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2014-07-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility 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

Primary outcomes:
measure: Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization.
timeFrame: 12 months
Secondary outcomes:
measure: Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans.
timeFrame: 12 months
measure: Comparison of Y-90 PET/CT to Y90 SPECT
timeFrame: 12 Months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Jackson Health System
state: Florida
Study officials:
affiliation: University of Miami
name: Jason Salsamendi, MD
role: PRINCIPAL_INVESTIGATOR
References: