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

• ClinicalTrials.gov Identifier: NCT01186263
• Recruitment Status: Completed
• First Posted: August 23, 2010
• Last Update Posted: September 4, 2014
• Sponsor: University of Magdeburg
• Collaborator: Sirtex Medical
• Information provided by (Responsible Party): Jens Ricke, University of Magdeburg

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Colorectal Cancer; Liver Metastases	Drug: MAA for diagnostic SPECT imaging; Drug: Diagnostic B20- SPECT imaging.	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 24 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• 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 Start Date: July 2010
• Actual Primary Completion Date: July 2011
• Actual Study Completion Date: August 2013

Arms and Interventions

Arm	Intervention/treatment
Experimental: 99mTc- labeled albumin macroaggregates (MAA); Diagnostic MAA- SPECT- imaging.	Drug: MAA for diagnostic SPECT imaging; Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.; Other Name: TechneScan Lyo MAA
Experimental: 99mTc- labeled albumin microspheres (B20); Diagnostic B20- SPECT- imaging.	Drug: Diagnostic B20- SPECT imaging.; Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.; Other Name: ROTOP HSA microspheres B20

Outcome Measures

Primary Outcome Measures :

1. Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy [ Time Frame: Tc-99m MAA scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy ]
   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.)

Secondary Outcome Measures :

1. Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy [ Time Frame: Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy ]
   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.)
2. Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20. [ Time Frame: One day prior to SIRT ]
   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)
3. Adverse events as elicited upon indirect questioning. [ Time Frame: At any visit. ]
   Number of patients with adverse events (AEs), number of AEs per patient; descriptive listing of all AEs

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Germany

Clinic for Radiology and Nuclear Medicine

Magdeburg, Sachsen-Anhalt, Germany, 39120

Sponsors and Collaborators

University of Magdeburg

Sirtex Medical

Investigators

• Principal Investigator: Jens Ricke, Prof. Dr.; University of Magdeburg, Faculty for Medicine

More Information

• Responsible Party: Jens Ricke, Prof. Dr., University of Magdeburg
• ClinicalTrials.gov Identifier: NCT01186263
• Other Study ID Numbers: RAD050; 2008-005609-21 ( EudraCT Number )
• First Posted: August 23, 2010
• Last Update Posted: September 4, 2014
• Last Verified: September 2014

Keywords provided by Jens Ricke, University of Magdeburg:

liver metastases; MAA; B20; SIR spheres; SPECT; intra-hepatic distribution

Additional relevant MeSH terms:

Neoplasm Metastasis; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Neoplastic Processes; Pathologic Processes; Liver Diseases