Clinical trial NCT01186263: Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy
Official title: Exploratory Study to Assess the Predictive Value of 99mTc-labeled Albumin Spheres for the Intrahepatic Distribution of 90Y SIR Spheres in Patients With Liver Metastases of Colorectal Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Liver Metastases
Keywords: liver metastases
MAA
B20
SIR spheres
SPECT
intra-hepatic distribution
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
Collaborators: name: Sirtex Medical
First posted: 2010-08-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy
timeFrame: Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
Secondary outcomes:
measure: Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy
timeFrame: Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy
measure: Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20.
timeFrame: One day prior to SIRT
measure: Adverse events as elicited upon indirect questioning.
timeFrame: At any visit.
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Clinic for Radiology and Nuclear Medicine
state: Sachsen-Anhalt
Study officials:
affiliation: University of Magdeburg, Faculty for Medicine
name: Jens Ricke, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: