Clinical trial · Interventional
Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
A Phase 1 Study of Combined Y-90 Selective Internal Radiation Therapy (Y-90 SIRT) and Stereotactic Body Radiation Therapy (SBRT) in Hepatic Malignancy.
- 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)
This study will investigate the combination of Ytrium-90 (Y-90) Selective Internal Radiation Therapy (SIRT) followed by Stereotactic Body Radiation Therapy (SBRT). Y-90 SIRT alone or SBRT alone are standard procedures used in the treatment of liver cancer. This study will assess the combination of Y-90 SIRT and SBRT and obtain preliminary information about the side effects and safety of the combination therapy. Additionally, this is the first time that Y-90 PET-CT imaging will be included in planning for SBRT.
Conditions
Conditions (1)
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 Malignancy | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PET/CT | Diagnostic Test | — | UNRESOLVED |
| Selective Internal Radiation Therapy | Device | — | UNRESOLVED |
| Stereotactic Body Radiation Therapy | Radiation | — | UNRESOLVED |
| Therasphere | Device | — | UNRESOLVED |
| Yttrium-90 | Drug | Yttrium-90 | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Y-90 SIRT followed by SBRT
- description
- Y-90 SIRT followed by SBRT
- interventionNames
- Drug: Yttrium-90
- Device: Selective Internal Radiation Therapy
- Radiation: Stereotactic Body Radiation Therapy
- Diagnostic Test: PET/CT
- Device: Therasphere
Primary outcomes (3)
- measure
- Change in Child-Turcotte-Pugh (CTP) score >= 2 points from baseline
- timeFrame
- Up to 6 months after SBRT
- description
- The primary safety endpoint is the binary indicator for a CTP increase of 2 or more points within 6 months and relative to pre-SBRT baseline. An increase of 2 or more points indicates clinically significant liver decompensation.
- measure
- Incidence of toxicities of grade 3 or higher
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of unresectable hepatocellular carcinoma or metastatic liver cancer. Hepatocellular carcinoma is defined as having at least one of the following: * Biopsy proven hepatocellular carcinoma (HCC); or * A discrete hepatic tumor(s) as defined by the Barcelona imaging criteria. Metastatic liver cancer is defined as having: o pathological confirmation of any metastatic disease with a new or enlarging liver lesion consistent with metastases. The targeted lesion does not need to be biopsied if the patient has a known history of metastatic disease * Patients must not have known untreated or progressive disease outside of the liver * At least one lesion \>2 cm diameter or 4 cc volume * Patients must have a life expectancy of at least 6 months. * Patients must be 18 years of age or older * All men, as well as women of childbearing potential, must agree to use effective contraception throughout the study and for 90 days following treatment. * Patients must understand and be willing to sign an informed consent form approved for this purpose by the Institutional Review Board (IRB) of the University of Michigan Medical Center indicating that they are aware of the investigational aspects of the treatment and the potential risks. Exclusion Criteria: * Inability to lie still for imaging studies (e.g. PET/CT) * Pregnancy or nursing females or refusal to use birth control in patients capable of reproduction. * Patients with known allergy or contraindication to intravenous iodinated contrast agents * Patients with an allergy or contraindication to MRI on MRI contrast (Eovist or Gadolinium) * Contraindication to Theraspheres * Tc-99m macroaggregated albumin (MAA) hepatic arterial perfusion scintigraphy showing any deposition to the gastrointestinal tract that may not be corrected by angiographic techniques * Shunting of blood to the lungs that could result in delivery of greater than 30 Gy to the lungs. * Hepatic artery catheterization contraindication; such as patients with vascular abnormalities or bleeding diathesis; * Bilirubin \>2.0 at baseline * Occlusion of the main portal vein * Contraindication to radiation therapy * Note: Patients who have an increase in bilirubin \>1.0 from the time of Y90 to SBRT or his/her bilirubin goes above 2.5 after Y90 will not be eligible for SBRT.
References
Publications (1)
- DERIVEDLu Z, Polan DF, Wei L, Aryal MP, Fitzpatrick K, Wang C, Cuneo KC, Evans JR, Roseland ME, Gemmete JJ, Christensen JA, Kapoor BS, Mikell JK, Cao Y, Mok GSP, Dewaraja YK. PET/CT-Based Absorbed Dose Maps in 90Y Selective Internal Radiation Therapy Correlate with Spatial Changes in Liver Function Derived from Dynamic MRI. J Nucl Med. 2024 Aug 1;65(8):1224-1230. doi: 10.2967/jnumed.124.267421. PMID 38960710