Status:
ACTIVE_NOT_RECRUITING
Radiotherapy With Iron Oxide Nanoparticles (SPION) on MR-Linac for Primary & Metastatic Hepatic Cancers
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Conditions:
Liver Neoplasms
Hepatic Cirrhosis
Eligibility:
All Genders
18-89 years
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 associate...
Detailed Description
Setting/Participants: The study will be performed at a single center - Allegheny General Hospital (AGH) in a setting of referral-based outpatients within the Allegheny Health (AHN) network. 25 patie...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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).
Key Trial Info
Start Date :
November 19 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04682847
Start Date
November 19 2020
End Date
December 31 2024
Last Update
January 31 2024
Active Locations (1)
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1
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212