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

University of Miami

Status: Completed

Conditions: Hepatic Tumors; Liver Cancer

Treatments: Device: PET/CT Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02202317

20120092

Details and patient eligibility

About

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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

Y90 Based PET/CT Scan

Experimental group

Treatment:

Device: PET/CT Scan