Primary Liver Tumor, Metastatic LiverNCT02761356
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 of Primary Liver Tumor, Metastatic Liver, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Liver Tumor, Metastatic Liver
- What is being tested?
- Tc99-MAA
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2010to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated with Yttrium-90 SIRT for liver malignancies
Who may be able to join
- 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.
Who cannot join
- 1. Age < 18. 2. Pregnant woman 3. Children and legally incompetent.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
Official title: The Added Value of Hybrid Functional Anatomical Imaging PET-CT and SPECT-CT in Patients Treated With Yttrium-90 SIRT for Liver
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:
- Collection of anamnestic data
- Calculation of liver tumor volume with quantification software
- Evaluation of the liver tumor involvement
- Evaluation of liver to lung shunt
- Calculation dose of SIRTEX
- Y90 imaging
- 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.
- In Angiography department
- 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.
- 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
- Primary Liver Tumor, Metastatic Liver
- Being tested
- Tc99-MAA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tc99-MAAOther
Also called Tc-99m-macroaggregated albumin
To evaluate the fisibility of Tc99-MAA injected intra epatic artery to predict uptake of Yttrium-90 SIRT in patients with liver malignancies
| Study group | Role | What they receive |
|---|---|---|
| Tc99-MAA and SPECT-CT | 26 of the patients were examined with Tc99-MAA and SPECT-C Receives: Other: Tc99-MAA | |
| Tc99-MAA , SPECT-CT and PET-CT | 24 patients were examined with Tc99-MAA , SPECT-CT and PET-CT. Receives: Other: Tc99-MAA |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startJan 2010
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Liver Tumor, Metastatic LiverStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Einat Even-Sapir, Phd, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02761356
- Sponsor's protocol ID
- TASMC-16-ES-0413-15-TLV-CTIL
- Status last verified
- May 2016
- First submitted
- 11 Feb 2016
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Added Value of Hybrid Functional Anatomical Imaging PET-CT and SPECT-CT in Patients Treated With Yttrium-90 SIRT for Liver
- ClinicalTrials.gov ID
- NCT02761356
- Acronym / sponsor ID
- TASMC-16-ES-0413-15-TLV-CTIL
- Conditions
- Primary Liver Tumor, Metastatic Liver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jan 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Collection of anamnestic data
- Calculation of liver tumor volume with quantification software
- Evaluation of the liver tumor involvement
- Evaluation of liver to lung shunt
- Calculation dose of SIRTEX
- Y90 imaging
- Follow Up
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.
- In Angiography department
- 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.
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tc99-MAA and SPECT-CT | – | Other: Tc99-MAA26 of the patients were examined with Tc99-MAA and SPECT-C |
| Tc99-MAA , SPECT-CT and PET-CT | – | Other: Tc99-MAA24 patients were examined with Tc99-MAA , SPECT-CT and PET-CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated with Yttrium-90 SIRT for liver malignancies
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 1. Age < 18. 2. Pregnant woman 3. Children and legally incompetent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tc99-MAAAlso: Tc-99m-macroaggregated albuminTo evaluate the fisibility of Tc99-MAA injected intra epatic artery to predict uptake of Yttrium-90 SIRT in patients with liver malignancies | Other | Tc99-MAA , SPECT-CT and PET-CT, Tc99-MAA and SPECT-CT |
Primary outcome
Visual assesment of Tc-99m-MAA in liver lesions compared to visual assesment of Y-90 sirtex.
Time frame: one year
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Einat Even-Sapir, Phd, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Liver Tumor, Metastatic Liver, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual assesment of Tc-99m-MAA in liver lesions compared to visual assesment of Y-90 sirtex. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2016.