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

Colorectal Cancer Clinical Trial

— EXPLOSIVE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01186263
• Other study ID #: RAD050
• Secondary ID: 2008-005609-21
• Status: Completed
• Phase: Phase 2
• First received: July 23, 2010
• Last updated: September 3, 2014
• Start date: July 2010
• Est. completion date: August 2013

Study information

• Verified date: September 2014
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2013
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Colorectal Cancer
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• MAA for diagnostic SPECT imaging
Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.
• Diagnostic B20- SPECT imaging.
Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.

Locations

Country	Name	City	State
Germany	Clinic for Radiology and Nuclear Medicine	Magdeburg	Sachsen-Anhalt

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	Sirtex Medical

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy	The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by Tc-99m MAA will be given by a blinded reader in categories by visual assessment (0-10%, >10-20%, >20-30%, …, >90-100%) (only patients who received Tc-99m MAA during evaluation.)	Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy	No
Secondary	Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy	The percentage in liver volume for which the accumulation of SIR spheres during therapy was correctly predicted by B20 will be given by a blinded reader in categories by visual assessment (0-10%, >10-20%, >20-30%, …, >90-100%) (only patients who received Tc-99m B20 during evaluation.)	Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy	No
Secondary	Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20.	elimination half-life calculated in [min] from the decay-corrected radioactivity concentration measured over the liver; % radioactivity trapped in the liver at the individual measuring time points (of total radioactivity measured over the liver in the first scan); percent lung shunt (percentage of liver activity leaking to the lung at the individual time points)	One day prior to SIRT	No
Secondary	Adverse events as elicited upon indirect questioning.	Number of patients with adverse events (AEs), number of AEs per patient; descriptive listing of all AEs	At any visit.	Yes