Skip to main content
OpenTrials
Completed

NCT Number: NCT01186263

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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Liver Metastases Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinic for Radiology and Nuclear Medicine

Magdeburg, Saxony-Anhalt, 39120, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MAA for diagnostic SPECT imaging

Drug

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

Other names: TechneScan Lyo MAA

Diagnostic B20- SPECT imaging.

Drug

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

Other names: ROTOP HSA microspheres B20

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Magdeburg

Other

Collaborators

  • Sirtex Medical

Registry information

Official study 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

Acronym: EXPLOSIVE

Important dates

Study start
2010
Primary completion
2011
Study completion
2013
First posted
Aug 23, 2010
Registry last updated
Sep 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.