Clinical trial · Observational
Radiotherapy With Iron Oxide Nanoparticles (SPION) on MR-Linac for Primary & Metastatic Hepatic Cancers
Adaptive Stereotactic Radiotherapy With Superparamagnetic Iron Oxide Nanoparticles (SPION) Cellular Magnetic Resonance Imaging on MR-Linac (MR-L-SPION) for Primary and Metastatic Hepatic Malignancies With Assessment of Treatment Response.
- 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)
There is a high prevalence of hepatic cirrhosis in patients with hepatocellular carcinomas (HCC), or chemotherapy-induced hepatic atrophy or hepatosteatosis in patients with liver metastases associated with high risk of radiation-induced liver disease (RILD) after stereotactic body radiotherapy (SBRT). MRI-SPION radiotherapy planning will facilitate detection and maximize avoidance of residual functionally active hepatic parenchyma from over-the-threshold irradiation thus increasing safety of liver SBRT in patients with pre-existing liver conditions. The investigators have previously demonstrated that liver SBRT with SPECT/CT functional treatment planning utilizing 99mTc sulfur colloid in transplant eligible patients associated with minimal hepatotoxicity and without hastening of advanced hepatic cirrhosis progression while patients await liver transplant. Switching from nuclear medicine to an MR-Linac-SPION based quantitative treatment-planning platform will substantially improve diagnostic accuracy in defining safe volumes of residual functional hepatic parenchyma for liver SBRT planning on MR-Linac.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatic Atrophy | — | UNRESOLVED | — |
| Hepatic Carcinoma | — | UNRESOLVED | — |
| Hepatic Cirrhosis | — | UNRESOLVED | — |
| Hepatocellular Cancer | Hepatocellular Carcinoma | CURATED_BROADER | 0.80 |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
| Liver Carcinoma | Liver Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Metastases | — | UNRESOLVED | — |
| Liver Neoplasms |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferumoxytol injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Primary and metastatic liver tumors and hepatic cirrhosis
- description
- This study is a single arm prospective study that will enroll 25 patients with primary and metastatic liver tumors and hepatic cirrhosis eligible for liver SBRT who will be receiving treatment at a single center - Allegheny General Hospital.
- interventionNames
- Drug: Ferumoxytol injection
Primary outcomes (1)
- measure
- Develop a platform to maintain liver functionality during treatment for liver cancer
- timeFrame
- Two Years
- description
- The primary goal of the study is to develop MRI-linac SPION based radiotherapy planning platform for detection and conformal avoidance of residual, functionally active hepatic parenchyma during liver SBRT for primary and metastatic hepatic malignancies in patients with hepatic cirrhosis. Treatment outcomes and toxicity due to improved conformal avoidance of functional normal liver volumes will be assessed for these patients. Progression in Child-Pugh and MELD scores, disease free survival, and overall survival (with and without liver transplant) will be evaluated via Kaplan Meier analysis. Freedom from MELD score progression will be measured against residual volumes of functionally active hepatic parenchyma defined on MRI-linac SPION via Cox proportional hazard regression models. Statistical analysis will be conducted with MedCalc version 11.3.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients age 18-89 years 2. Women of childbearing age must have a negative urine/serum pregnancy test (per standard of care) and must use an acceptable method of contraception, including abstinence, a barrier method (diaphragm or condom), Depo-Provera, or an oral contraceptive, for the duration of the study Women beyond childbearing are not required to use contraception. 3. Child-Pugh A or B liver function; 4. Child-Pugh C liver function for transplant eligible patients only. 5. Single or multinodular tumors (up to four) are permitted. 6. Patients required to have more than 30% of functionally active uninvolved liver outside radiation target volume; 7. No prior liver radiation, including radioembolization; 8. ECOG (Eastern Cooperative Oncology Group) performance score \>=2 Exclusion Criteria: 1. Patients over 90 year of age 2. Bilirubin x3 upper limit of normal; 3. AST (aspartate aminotransferase) or ALT (alanine transaminase) x6 upper limit of normal; 4. Hemoglobin less than 80 g/L; 5. Patients with recurrent ascites (paracentesis q ≥2 weeks); 6. Patients with history of hypersensitivity to Feraheme or any other IV iron products; 7. Patients with hemochromatosis (iron overload).
References
Publications (0)
Data not yet available