Clinical trial · Observational
Radiolabeled Glass Beads in Treating Patients With Metastatic Liver Cancer That Cannot Be Removed by Surgery
A Humanitarian Device Exemption Compassionate Use Protocol of TheraSphere for Treatment of Unresectable Metastatic Cancer to the Liver
- 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)
RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Using radiolabeled glass beads to kill tumor cells may be effective treatment for liver cancer that cannot be removed by surgery. PURPOSE: This phase II trial is studying how well radiolabeled glass beads work in treating patients with metastatic liver cancer that cannot be removed by surgery.
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 |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Yttrium Y 90 glass microspheres | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All Patients
- description
- Patients with metastatic cancer of the liver who are not surgical resection candidates and who will be treated with TheraSphere per institutional standard of care.
- interventionNames
- Radiation: Yttrium Y 90 glass microspheres
Primary outcomes (0)
[]Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Confirmed diagnosis of metastatic intrahepatic carcinoma * Histopathology confirmation may be waived in patients with a radiographically identifiable liver mass AND known laboratory or clinical risk factors for cancer or elevated tumor markers such as AFP * Unresectable disease * No portal hypertension with portal venous shunt away from the liver * FDA approval to receive compassionate use of yttrium Y 90 glass microspheres * No significant extrahepatic disease representing an imminent life-threatening outcome * No evidence of potential delivery of \> 16.5 mCi (30 Gy absorbed dose) of radiation to the lungs on either of the following: * First administration of yttrium Y 90 glass microspheres (TheraSphere ®) * Cumulative delivery of radiotherapy to the lungs over multiple treatments PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy ≥ 3 months * Absolute granulocyte count ≥ 1,500/µL * Platelet count ≥ 25,000/μL * Creatinine ≤ 2.0 mg/dL (unless using non-iodinated contrast or on dialysis) * Serum bilirubin ≤ 3.0 mg/dL (in some cases where there is an elevated bilirubin, and the tumor may be isolated from a vascular standpoint, treatment may proceed) * No contraindication to angiography or selective visceral catheterization, including any of the following: * History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine, that cannot be controlled using basic angiographic techniques * Bleeding diathesis, not correctable by usual forms of therapy * Severe peripheral vascular disease that would preclude catheterization * No severe liver dysfunction or pulmonary insufficiency * No active uncontrolled infection * No significant underlying medical or psychiatric illness * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No evidence of any detectable technetium-99 macroaggregated albumin (Tc-99 MAA) flow to the stomach or duodenum after application of established angiographic techniques to stop such flow * No comorbid disease or condition that would preclude safe delivery of yttrium Y 90 glass microspheres and place patient at undue risk PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior radiotherapy * More than 2 weeks since prior surgery * At least 2 weeks since prior radiosensitizing chemotherapy * More than 6 weeks since prior carmustine (BCNU) or mitomycin C * No other concurrent cancer therapy
References
Publications (2)
- RESULTRhee TK, Lewandowski RJ, Liu DM, Mulcahy MF, Takahashi G, Hansen PD, Benson AB 3rd, Kennedy AS, Omary RA, Salem R. 90Y Radioembolization for metastatic neuroendocrine liver tumors: preliminary results from a multi-institutional experience. Ann Surg. 2008 Jun;247(6):1029-35. doi: 10.1097/SLA.0b013e3181728a45. PMID 18520231
- RESULTSato KT, Lewandowski RJ, Mulcahy MF, Atassi B, Ryu RK, Gates VL, Nemcek AA Jr, Barakat O, Benson A 3rd, Mandal R, Talamonti M, Wong CY, Miller FH, Newman SB, Shaw JM, Thurston KG, Omary RA, Salem R. Unresectable chemorefractory liver metastases: radioembolization with 90Y microspheres--safety, efficacy, and survival. Radiology. 2008 May;247(2):507-15. doi: 10.1148/radiol.2472062029. Epub 2008 Mar 18. PMID 18349311