Clinical Trials Logo

Clinical Trial Summary

This is a Phase 1 pilot study to assess feasibility and utility of 99mTc-mebrofenin hepatobiliary scintigraphy for measurement of functional liver change due to radiotherapy.


Clinical Trial Description

Patients with cancers of the liver who are not suitable for surgery or chemo/radio embolisation are often treated with stereotactic ablative body radiotherapy (SABR). SABR results in high local control rates but, similar to other treatment modalities, carries risk of damage to healthy surrounding liver. This study aims to use a novel nuclear medicine imaging tracer, 99mTcMebrofenin, to evaluate liver function before and after radiotherapy. Patients will have a 99mTcMebrofenin scan performed < 2 weeks before radiotherapy and 1 and 6 months after radiotherapy. At the same time points, indocyanine green (ICG) and liver elasticity tests will be performed. These are global measures of liver function, whereas 99mTcMebrofenin is both global and local. From the imaging data, the Investigators will be able to correlate change in local liver function in each sub volume of the liver with the radiotherapy dose it received. The Investigators will be able to thus measure the effect of radiotherapy on global and local liver function. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02967848
Study type Observational
Source Royal North Shore Hospital
Contact
Status Active, not recruiting
Phase
Start date October 19, 2016
Completion date December 31, 2024

See also
  Status Clinical Trial Phase
Recruiting NCT03674073 - A Study Combining Personalized Neoantigen-based Dendritic Cell Vaccine With Microwave Ablation for the Treatment of Hepatocellular Carcinoma Phase 1
Terminated NCT02704130 - TAE and MWA Combination Therapy in Early-stage Hepatocellular Carcinoma N/A
Recruiting NCT04864054 - T-Cell Therapy (ECT204) in Adults With Advanced HCC Phase 2
Not yet recruiting NCT05195294 - Study of HBV-TCR T Cells (LioCyx-M) as Monotherapy or as Combination With Lenvatinib for HBV-related HCC Phase 1/Phase 2
Completed NCT02191878 - Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma Phase 1/Phase 2
Terminated NCT00669136 - Immunization With AFP + GM CSF Plasmid Prime and AFP Adenoviral Vector Boost in Patients With Hepatocellular Carcinoma Phase 1
Active, not recruiting NCT04567615 - A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors Phase 2
Recruiting NCT05705219 - Development of 3DMPUS as a Decision Support Tool for Patients With Liver Tumors Undergoing Therapy N/A
Terminated NCT02527577 - Analgesia by Transversus Abdominis Plane Nerve Block in Patients Undergoing Liver Resection. N/A