Radiotherapy With Iron Oxide Nanoparticles (SPION) on MR-Linac for Primary & Metastatic Hepatic Cancers

NCT04682847 | Unknown DMC FDA Drug

• 1 other identifier: 2020-212
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Liver Neoplasms; Hepatic Cirrhosis; Hepatic Carcinoma; Liver Cancer; Liver Metastases; Liver Carcinoma; Hepatocellular Carcinoma; Hepatocellular Cancer; Hepatic Atrophy

Keywords

Liver; Liver Cancer; Liver Carcinoma; Liver Metastases

Outcome Measures

Primary Outcomes (1)

• Develop a platform to maintain liver functionality during treatment for liver cancer

  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.

  Two Years

Secondary Outcomes (2)

• Develop applications for assessing the liver functionality of those with liver cancer

  Two Years

• Examine the dose-response of tumor and liver tissue in patients who received liver transplant after receiving SBRT

  Two Years

Study Arms (1)

Primary and metastatic liver tumors and hepatic cirrhosis

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.

Drug: Ferumoxytol injection

Interventions

Ferumoxytol injection DRUG

This is a prospective observation study of 1.5T MR-Linac-SPION imaging with Ferumoxytol for radiotherapy planning in patients with pre-existing liver condition in order to increase safety of liver SBRT with assessment of tumor and hepatic parenchyma response.

Also known as: Feraheme™ (ferumoxytol) Injection

Primary and metastatic liver tumors and hepatic cirrhosis

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with primary and metastatic liver tumors and hepatic cirrhosis eligible for liver SBRT will be enrolled in this study who will be receiving treatment at Allegheny General Hospital, Pittsburgh, PA.

You may qualify if:

• Patients age 18-89 years
• 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.
• Child-Pugh A or B liver function;
• Child-Pugh C liver function for transplant eligible patients only.
• Single or multinodular tumors (up to four) are permitted.
• Patients required to have more than 30% of functionally active uninvolved liver outside radiation target volume;
• No prior liver radiation, including radioembolization;
• ECOG (Eastern Cooperative Oncology Group) performance score \>=2

You may not qualify if:

• Patients over 90 year of age
• Bilirubin x3 upper limit of normal;
• AST (aspartate aminotransferase) or ALT (alanine transaminase) x6 upper limit of normal;
• Hemoglobin less than 80 g/L;
• Patients with recurrent ascites (paracentesis q ≥2 weeks);
• Patients with history of hypersensitivity to Feraheme or any other IV iron products;
• Patients with hemochromatosis (iron overload).

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead

Study Sites (1)

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and tumor samples

MeSH Terms

Conditions

Liver Neoplasms; Liver Cirrhosis; Carcinoma, Hepatocellular

Interventions

Ferrosoferric Oxide; Injections

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Alexander Kirichenko, MD, PhD

  Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Temple University School of Medicine System Director Stereotactic Body Radiotherapy and GI Cancer Programs Division of Radiation Oncology Allegheny Health Network Cancer Institute

Study Record Dates

• First Submitted: November 24, 2020
• First Posted: December 24, 2020
• Study Start: November 19, 2020
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)