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

3. september 2014 opdateret af: Jens Ricke, University of Magdeburg

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

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).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyskland
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Tyskland, 39120
        • Clinic for Radiology and Nuclear Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 85 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Diagnostisk
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 99mTc- labeled albumin macroaggregates (MAA)
Diagnostic MAA- SPECT- imaging.
Medicin: MAA for diagnostic SPECT imaging
Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.
Andre navne:
  • TechneScan Lyo MAA
Eksperimentel: 99mTc- labeled albumin microspheres (B20)
Diagnostic B20- SPECT- imaging.
Medicin: Diagnostic B20- SPECT imaging.
Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.
Andre navne:
  • ROTOP HSA microspheres B20

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy
Tidsramme: 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.)
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.
Tidsramme: 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)
One day prior to SIRT
Adverse events as elicited upon indirect questioning.
Tidsramme: At any visit.
Number of patients with adverse events (AEs), number of AEs per patient; descriptive listing of all AEs
At any visit.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Magdeburg

Samarbejdspartnere

Sirtex Medical

Efterforskere

  • Ledende efterforsker: Jens Ricke, Prof. Dr., University of Magdeburg, Faculty for Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juli 2010

Primær færdiggørelse (Faktiske)

1. juli 2011

Studieafslutning (Faktiske)

1. august 2013

Datoer for studieregistrering

Først indsendt

23. juli 2010

Først indsendt, der opfyldte QC-kriterier

20. august 2010

Først opslået (Skøn)

23. august 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

4. september 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. september 2014

Sidst verificeret

1. september 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • RAD050
  • 2008-005609-21 (EudraCT nummer)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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