Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy

NCT ID: NCT01186263

Last Updated: 2014-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2013-08-31

Brief Summary

The purpose of this study is to assess the predictive value of 99mTechnetium (Tc)- labeled albumin in macroaggregates (MAA) and in microspheres (B20) injected into the common hepatic artery for the distribution of 90Yttrium- Selective Internal Radiotherapy (SIRT)-spheres (SIR- spheres).

Detailed Description

Patients with metastases of colorectal tumors will be included into this study provided that they are scheduled for 90Y SIR spheres therapy for clinical reasons. Before 90Y SIR spheres therapy, patients will receive a diagnostic examination with injection of MAA (group A) or B20 (group B) into the common hepatic artery to rule out a relevant shunt volume to the lung or other extra-hepatic locations (e.g., stomach) as recommended by the manufacturer. After the diagnostic scan, therapy with SIR- spheres will be conducted in 2 separate sessions with selective injection of 90Y labeled SIR spheres into the right and left hepatic artery at two separate occasions (routine procedure at the University of Magdeburg, Germany). In addition, therapeutic sessions will include the selective injection of MAA or B20 into the right / left hepatic artery according to a predefined plan (either alone or as a mixture with the SIR spheres).The intra-hepatic distribution of 90Y labeled SIR spheres will be assessed using "Bremsstrahlen"- Single- Photon- Emission- Computed- Tomography (SPECT)- imaging, the distribution of MAA and B20 will be assessed using SPECT imaging.

Conditions

Colorectal Cancer; Liver Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

99mTc- labeled albumin macroaggregates (MAA)

Diagnostic MAA- SPECT- imaging.

Group Type: EXPERIMENTAL

MAA for diagnostic SPECT imaging

Intervention Type: DRUG

Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.

99mTc- labeled albumin microspheres (B20)

Diagnostic B20- SPECT- imaging.

Group Type: EXPERIMENTAL

Diagnostic B20- SPECT imaging.

Intervention Type: DRUG

Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.

Interventions

MAA for diagnostic SPECT imaging

Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.

Intervention Type: DRUG

Diagnostic B20- SPECT imaging.

Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.

Intervention Type: DRUG

Other Intervention Names

TechneScan Lyo MAA; ROTOP HSA microspheres B20

Eligibility Criteria

Inclusion Criteria

• age: between 18 and 85 years
• if female, postmenopausal or surgically sterilized
• liver metastases of a colorectal tumor in both liver lobes
• scheduled for therapy with 90Y SIR spheres for clinical reasons
• life expectancy longer than 6 months
• willing and able to undergo all study procedures
• having voluntarily provided written and fully informed consent

Exclusion Criteria

• presenting with a contraindication to 90Y SIR spheres therapy
• variants of the arterial hepatic blood supply which interfere with the objectives of this study (e.g., variants of Michel)
• women who are pregnant, lactating or who are of childbearing potential
• patients being clinically unstable
• uncooperative, in the investigator's opinion
• any contraindication to SIRT treatment
• any concomitant chemotherapy
• shunt to the lung >10%
• shunt to any extrahepatic organ (except the lung)
• having been previously enrolled in this study
• participating in another prospective clinical trial

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sirtex Medical

INDUSTRY

Sponsor Role: collaborator

University of Magdeburg

OTHER

Sponsor Role: lead

Responsible Party

Jens Ricke

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jens Ricke, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Magdeburg, Faculty for Medicine

Locations

Clinic for Radiology and Nuclear Medicine

Magdeburg, Saxony-Anhalt, Germany

Countries

Germany

Other Identifiers

2008-005609-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

RAD050

Identifier Type: -

Identifier Source: org_study_id