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CompletedNCT02761356Updated May 4, 2016

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

An observational study in Primary Liver Tumor, Metastatic Liver, sponsored by Tel-Aviv Sourasky Medical Center. Completed at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-04.

Sponsored by Tel-Aviv Sourasky Medical Center · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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
Read the detailed 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.

02

Conditions studied

  • Primary Liver Tumor, Metastatic Liver
03

In context

Lead sponsor

Tel-Aviv Sourasky Medical Center is the lead sponsor of 553 studies on the registry; 50 are open to participants now.

Browse Tel-Aviv Sourasky Medical Center studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients treated with Yttrium-90 SIRT for liver malignancies

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • 1. Age \< 18. 2. Pregnant woman 3. Children and legally incompetent.
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
50 participants (actual)
Patient registry
No

Groups and cohorts

  • Tc99-MAA and SPECT-CT

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

    Other: Tc99-MAA

  • Tc99-MAA , SPECT-CT and PET-CT

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

    Other: Tc99-MAA

Interventions

  • OtherTc99-MAA

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

    Also known as: Tc-99m-macroaggregated albumin

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: one year

07

Study locations

1 site
  • Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
    Tel Aviv, Israel
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2010, a primary completion of Aug 2015 and a completion of Aug 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2016
First posted
May 4, 2016
Start
Jan 2010
Primary completionActual
Aug 2015
CompletionActual
Aug 2015
Last update
May 4, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 4, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02761356
Lead sponsor
Tel-Aviv Sourasky Medical Center
Responsible party
Sponsor
First posted
May 4, 2016
Start date
Jan 2010
Primary completion
Aug 2015
Completion
Aug 2015
Last update
May 4, 2016

Study contacts

Einat Even-Sapir, Phd, MD
principal investigator · Tel-Aviv Sourasky Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2016. You cannot join it, but the record below documents what was studied.

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