The Added Value of Hybrid Functional Anatomical Imaging PET-CT and SPECT-CT in Patients Treated With Y-90 SIRT for Liver Malignancies

Primary Liver Tumor, Metastatic Liver Clinical Trial

Official title:

The Added Value of Hybrid Functional Anatomical Imaging PET-CT and SPECT-CT in Patients Treated With Yttrium-90 SIRT for Liver

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02761356
• Other study ID #: TASMC-16-ES-0413-15-TLV-CTIL
• Status: Completed
• Phase: N/A
• First received: February 11, 2016
• Last updated: May 2, 2016
• Start date: January 2010
• Est. completion date: August 2015

Study information

• Verified date: May 2016
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Patients cohort is composed of 50 consecutive patients both male and female with hepatic malignancies, refered to our nuclear medicine department in the process of radioembolization between January 2010- August 2015. 26 of the patients were examined with Tc99-MAA and SPECT-CT and 24 patients were examined with Tc99-MAA , SPECT-CT and PET-CT. Our study protocol was as follows:

1. Collection of anamnestic data

2. Calculation of liver tumor volume with quantification software

3. Evaluation of the liver tumor involvement

4. Evaluation of liver to lung shunt

5. Calculation dose of SIRTEX

6. Y90 imaging

7. Follow Up

Description:

The description of the various stages that the patient goes through SIRTex treatment in the department of nuclear medicine and their roll in the study is as following:

The first stage is dedicated to the evaluation of the patient's illegibility for the treatment.

1. In Angiography department

2. In Nuclear medicine department assessment of liver-lung shunting (planar images). Followed by SPECT-CT of the upper abdomen. SPECT with Low dose CT is used to identify a leak to the stomach, duodenum and mesentery, as well as to assess uptake of Tc-99m-MAA in tumor lesions. In order to increase SPECT-CT resolution and sensitivity we co-registrated SPECT-CT with diagnostic CT provided from previous contrast enhanced CT or PET-CT. In this procedure, the Low dose CT is used as bridge between diagnostic CT and the functional imaging SPECT.

3. Calculation dose of Sirtex therapy. At this stage the purpose of the study will be to investigate the added value of SPECT-CT in the estimation of Tc-99m-MAA uptake in tumor lesions.

The second stage is dedicated to the assessment Y-90-SIRTex uptake in liver tumors and to exclude extra hepatic leak. Several hours after treatment patients perform SPECT-CT using Brummshtrullung emission or PET-CT with the peak Zr-90.

At this stage , in our study, we will compare liver lesions uptake of Tc-99m-MAA in the SPECT-CT to lesions uptake of Y-90 -SIRT SPECT/PET-CT as well as to assess if SPECT-CT withTc-99m-MAA may be used as a predictor of Y-90-SIRTex uptake in liver lesion. Does SPECT-CT with Tc-99m-MAA change patient managment.

The third stage of the study is the collection and monitoring of post treatment outcome data.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 1. Age = 18. 2. Patients with malignancy of the liver (metastasis or primary tumor) who were treated with Y90 SIRT and were refered to the nuclear medicine department for a PET-CT.

Exclusion Criteria:

• 1. Age < 18. 2. Pregnant woman 3. Children and legally incompetent.

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Primary Liver Tumor, Metastatic Liver

Intervention

Other:
• Tc99-MAA
To evaluate the fisibility of Tc99-MAA injected intra epatic artery to predict uptake of Yttrium-90 SIRT in patients with liver malignancies

Locations

Country	Name	City	State
Israel	Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual assesment of Tc-99m-MAA in liver lesions compared to visual assesment of Y-90 sirtex.	Undestanding the role of Tc-99- MAA in the prediction of Y90 sirt uptake in liver lesions by visual assesment with PET-CT and SPECT-CT imaging	one year	No