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

University of Magdeburg

Status and phase

Completed

Phase 2

Conditions

Liver Metastases

Colorectal Cancer

Treatments

Drug: Diagnostic B20- SPECT imaging.

Drug: MAA for diagnostic SPECT imaging

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01186263

2008-005609-21 (EudraCT Number)

RAD050

Details and patient eligibility

About

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).

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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