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

NCT01186263 | Completed Phase 2

• 2 other identifiers: RAD0502008-005609-21
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Cancer; Liver Metastases

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy

  Tc-99m B20 scan one day prior to radioembolisation; Bremsstahlen-Scan after SIR spheres therapy

• Pharmacokinetic parameters of the intrahepatic distribution of MAA and B20.

  One day prior to SIRT

• Adverse events as elicited upon indirect questioning.

  At any visit.

Study Arms (2)

99mTc- labeled albumin macroaggregates (MAA)

EXPERIMENTAL

Diagnostic MAA- SPECT- imaging.

Drug: MAA for diagnostic SPECT imaging

99mTc- labeled albumin microspheres (B20)

EXPERIMENTAL

Diagnostic B20- SPECT- imaging.

Drug: Diagnostic B20- SPECT imaging.

Interventions

MAA for diagnostic SPECT imaging DRUG

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

Also known as: TechneScan Lyo MAA

99mTc- labeled albumin macroaggregates (MAA)

Diagnostic B20- SPECT imaging. DRUG

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

Also known as: ROTOP HSA microspheres B20

99mTc- labeled albumin microspheres (B20)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Magdeburg: lead
• Sirtex Medical: collaborator

Study Sites (1)

Clinic for Radiology and Nuclear Medicine

Magdeburg, Saxony-Anhalt, 39120, Germany

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Jens Ricke, Prof. Dr.

  University of Magdeburg, Faculty for Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: August 23, 2010
• Study Start: July 1, 2010
• Primary Completion: July 1, 2011
• Study Completion: August 1, 2013
• Last Updated: September 4, 2014

Record last verified: 2014-09

Locations

DE (1)