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

NCT ID: NCT02761356

Last Updated: 2016-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2015-08-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Primary Liver Tumor, Metastatic Liver

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Tc99-MAA and SPECT-CT

26 of the patients were examined with Tc99-MAA and SPECT-C

Tc99-MAA

Intervention Type OTHER

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

Tc99-MAA , SPECT-CT and PET-CT

24 patients were examined with Tc99-MAA , SPECT-CT and PET-CT.

Tc99-MAA

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Other Intervention Names

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Tc-99m-macroaggregated albumin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tel-Aviv Sourasky Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Einat Even-Sapir, Phd, MD

Role: PRINCIPAL_INVESTIGATOR

Tel-Aviv Sourasky Medical Center

Locations

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Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Site Status

Countries

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Israel

Other Identifiers

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TASMC-16-ES-0413-15-TLV-CTIL

Identifier Type: -

Identifier Source: org_study_id

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