Clinical trial · Interventional
Predictive Value of 99mTc- Albumin Spheres Before 90Y- SIR Therapy
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
NCT01186263CI-TRIAL-00015539EXPLOSIVEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Liver Metastases | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diagnostic B20- SPECT imaging. | Drug | — | UNRESOLVED |
| MAA for diagnostic SPECT imaging | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 99mTc- labeled albumin macroaggregates (MAA)
- description
- Diagnostic MAA- SPECT- imaging.
- interventionNames
- Drug: MAA for diagnostic SPECT imaging
- type
- EXPERIMENTAL
- label
- 99mTc- labeled albumin microspheres (B20)
- description
- Diagnostic B20- SPECT- imaging.
- interventionNames
- Drug: Diagnostic B20- SPECT imaging.
Primary outcomes (1)
- measure
- Percentage of liver volume for which the accumulation of SIR spheres was correctly predicted by the preceding Tc-99m MAA scintigraphy
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.