Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy (EXPLOSIVE)
3 september 2014 uppdaterad av: 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).
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Fas 2
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Sachsen-Anhalt
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Magdeburg, Sachsen-Anhalt, Tyskland, 39120
- Clinic for Radiology and Nuclear Medicine
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 85 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 99mTc- labeled albumin macroaggregates (MAA)
Diagnostic MAA- SPECT- imaging.
|
Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.
Andra namn:
|
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Experimentell: 99mTc- labeled albumin microspheres (B20)
Diagnostic B20- SPECT- imaging.
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Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m B20 scintigraphy
Tidsram: 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.
Tidsram: 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)
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One day prior to SIRT
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Adverse events as elicited upon indirect questioning.
Tidsram: At any visit.
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Number of patients with adverse events (AEs), number of AEs per patient; descriptive listing of all AEs
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At any visit.
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Jens Ricke, Prof. Dr., University of Magdeburg, Faculty for Medicine
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juli 2010
Primärt slutförande (Faktisk)
1 juli 2011
Avslutad studie (Faktisk)
1 augusti 2013
Studieregistreringsdatum
Först inskickad
23 juli 2010
Först inskickad som uppfyllde QC-kriterierna
20 augusti 2010
Första postat (Uppskatta)
23 augusti 2010
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
4 september 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
3 september 2014
Senast verifierad
1 september 2014
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- RAD050
- 2008-005609-21 (EudraCT-nummer)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .