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

NCT02761356 | Completed

• 1 other identifier: TASMC-16-ES-0413-15-TLV-CTIL
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 1.Collection of anamnestic data
2. 2.Calculation of liver tumor volume with quantification software
3. 3.Evaluation of the liver tumor involvement
4. 4.Evaluation of liver to lung shunt
5. 5.Calculation dose of SIRTEX
6. 6.Y90 imaging
7. 7.Follow Up

Conditions

Primary Liver Tumor, Metastatic Liver

Outcome Measures

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

  one year

Study Arms (2)

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

Tc99-MAA OTHER

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

Tc99-MAA , SPECT-CT and PET-CT; Tc99-MAA and SPECT-CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients treated with Yttrium-90 SIRT for liver malignancies

You may qualify if:

• \. 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.

You may not qualify if:

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

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Interventions

technetium Tc 99m-Sn aggregated albumin

Study Officials

• Einat Even-Sapir, Phd, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2016
• First Posted: May 4, 2016
• Study Start: January 1, 2010
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: May 4, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)