Clinical trial · Interventional
TheraSphere® For Treatment of Metastases in Liver
Feasibility of a Personalized Dosimetry-based Treatment Planning for Radioembolization in the Treatment of Unresectable Colorectal Metastases in Liver
NCT04517643CI-TRIAL-00070267completedN/AResults postedClinicalTrials.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)
To investigate whether the dose predicted by pre-therapy 99mTc MAA SPECT predicts the dose to the liver from the 90Y microspheres as assessed by post-therapy 90Y SPECT/CT or positron emission tomography (PET)/CT.
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 |
| Colorectal Cancer Metastatic | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Therasphere Therapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Therasphere Therapy
- description
- All participants will receive the Therasphere Therapy.
- interventionNames
- Other: Therasphere Therapy
Primary outcomes (1)
- measure
- Number of Patients That Met the Criterion That the Dose Estimated With Tc-99m MAA SPECT Was Within 15% of the Dose Estimated From Y-90 SPECT
- timeFrame
- Pre-Treatment and up to 6 hours Post-Treatment
- description
- Change in dose estimates of radioactivity from Therasphere treatment to liver tumor target, measured in Gray, will be compared at pre-treatment and up to 6 hours post-treatment. Reported as number of patients that met the criterion that the dose estimated with Tc-99m MAA SPECT was within 15% of the dose estimated from Y-90 SPECT
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * The Diagnosis of metastatic colorectal cancer to the liver * Patients with a diagnosis of metastatic colorectal cancer to the liver * Liver metastases are unresectable * Tumors are hypervascular based on visual estimation by the Investigator * Target tumors are measurable using standard imaging techniques * Performance Status Score 0 - 2 * Age ≥18 years * Life expectancy ≥3 months * \>4 weeks since prior radiation, surgery or chemotherapy * Able to comprehend and provide written informed consent in accordance with institutional and federal guidelines * At least one month has elapsed since most recent prior cancer therapy with the following exception: * Patient is willing to participate in the study and has signed the study informed consent Exclusion Criteria: Patients may not be treated with TheraSphere® if patients have any of the following exclusions: * Any pre-treatment laboratory findings within 15 days of treatment demonstrating liver dysfunction: * Blood test result levels outside of the normal range * Any history of hepatic encephalopathy * Any contraindications to angiography and hepatic artery catheterization such as: * History of severe allergy or intolerance to any contrast media, narcotics, sedatives or atropine that cannot be corrected or premedicated * Bleeding diathesis, not correctable by usual forms of therapy * Severe peripheral vascular disease that would preclude catheterization. * Evidence of pulmonary insufficiency * Significant extrahepatic disease representing an imminent life-threatening outcome * Active uncontrolled infection * Significant underlying medical or psychiatric illness * Co-morbid disease or condition that would preclude safe delivery of TheraSphere® treatment or, in the judgment of the physician, place the patient at undue risk * Pregnancy * Special Categories of Patients: Not applicable * Research in Mentally Disabled People: No. All participants or legal guardians will be fully able to give informed consent.
References
Publications (0)
Data not yet available
No reference posted for this study.