Liver Cancer Clinical Trial
Official title:
A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver
The primary question of interest is quantifying the relationship between Y-90 liver therapy
and liver damage. Little is known on this subject. Present assumptions and calculations of
Y-90 administration are based on surgical lobar hepatectomies and external radiation beam
therapies. The investigators hope that by using a functional model of the liver, the
investigators can improve this important knowledge gap.
The investigators will be enrolling patients planning to receive Y-90 therapy for the
treatment of liver malignancies. The diagnosis of a primary liver cancer, hepatocellular
carcinoma (HCC), is usually made by a combination of specific imaging findings and clinical
criteria; only rarely is a confirmatory biopsy performed. This is due to the high accuracy of
the present diagnostic model and the significant risk of biopsy and tumor seeding.
Y-90 therapy involves administering radioactive particles to liver tumors by placing a
catheter in a hepatic artery supplying the tumor using angiographic techniques and injection
of these particles.
Y-90 Positron Emission Tomography-Computed Tomography (PET/CT) imaging has been established
as a method to validate and quantitate distribution of Yttrium after Y-90 administration. The
post Y-90 therapy PET/CT images provide an imaging distribution of the Y-90, which is
essential for validation of administered versus planned dose to the liver lesion and
background liver.
If the investigators can compare the Y-90 distribution to estimate background liver radiation
distribution and dose (generated by the Y-90 PET/CT scan) combined with the global and
regional function map (generated by the hepatobiliary [HIDA] scan performed before and after
therapy), then the investigators will be assuming that the difference pre and post therapy in
global and regional function can be ascribed to the Y-90 administration. The investigators
will also analyze the Magnetic Resonance Imaging (MRI) and CT sets performed before and after
therapy and correlate the imaging results collected with clinical findings such as
ascites/encephalopathy and routine serological markers (bilirubin, albumin, International
normalized ratio [INR], etc.). With this information, the investigators will have the
potential to establish whether there is a relationship between Y-90 distribution to
non-tumoral (normal) hepatic parenchyma and the incidence and severity of
Radioembolization-Induced Liver Disease (REILD). This would have the potential to improve
selection criteria and outcomes in populations selected for Y-90 therapy in the future.
Little is known on the potential relationship between Y-90 liver therapy and liver damage
this subject. Present assumptions and calculations of Y-90 administration are based on
surgical lobar hepatectomies and external radiation beam therapies.
As most participants that need Y90 based liver therapies have compromised livers, the
importance of knowing what potential collateral liver damage could be induced by Y90 is key
so as not induce liver failure. Successful treatment of a liver malignancy would not be
important if the potential mortality/morbidity risk of the treatment is higher or equal to
the existing malignancy.
As apposed to anatomical imaging looking for changes in size/shape which are late changes,
the investigators hope that by using a functional model of the liver, which can show early
changes of liver damage, the investigators can improve the sensitivity for detection of liver
damage and bridge this important knowledge gap. Additionally due to compensatory hypertrophy
of the non treated liver, potential liver damage estimated by lab tests may be masked, again
this emphasizes the importance of the measurement of the functional approach before and after
therapy.
The investigators will be enrolling participants planning to receive Y-90 therapy for the
treatment of liver malignancies. The diagnosis of a primary liver cancer, hepatocellular
carcinoma (HCC), is usually made by a combination of specific imaging findings and clinical
criteria; only rarely is a confirmatory biopsy performed. This is due to the high accuracy of
the present diagnostic model and the significant risk of biopsy and tumor seeding.
Y-90 therapy involves administering radioactive particles to liver tumors by placing a
catheter in a hepatic artery supplying the tumor using angiographic techniques and injection
of these particles.
Y-90 PET/CT imaging has been established as a method to validate and quantitate distribution
of Yttrium after Y-90 administration. The post Y-90 therapy PET/CT images provide an imaging
distribution of the Y-90, which is essential for validation of administered versus planned
dose to the liver lesion and background liver.
The investigators will be performing both specialized nuclear medicine HIDA and MRI scans
aimed at constructing a functional map of the liver before and 3 months after therapy.
The investigators will compare the Y-90 distribution to estimate background liver radiation
distribution and dose (generated by the Y-90 PET/CT scan) combined with the global and
regional function map (generated by the HIDA and MRI scans performed before and after
therapy), then the investigators will be assuming that the difference pre and post therapy in
global and regional function can be ascribed to the Y-90 administration.
The investigators will also analyze the MRI and NM data sets performed before and after
therapy and correlate the imaging results collected with clinical findings such as
ascites/encephalopathy and routine serological markers (bilirubin, albumin, INR, etc.).
With this information, the investigators will have the potential to establish whether there
is a relationship between Y-90 distribution to non-tumoral (normal) hepatic parenchyma and
the incidence and severity of REILD. This would have the potential to improve selection
criteria and outcomes in populations selected for Y-90 therapy in the future.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03213314 -
HepaT1ca: Quantifying Liver Health in Surgical Candidates for Liver Malignancies
|
N/A | |
| Not yet recruiting |
NCT04931420 -
Study Comparing Standard of Care Chemotherapy With/ Without Sequential Cytoreductive Surgery for Patients With Metastatic Foregut Cancer and Undetectable Circulating Tumor-Deoxyribose Nucleic Acid Levels
|
Phase 2 | |
| Terminated |
NCT00788125 -
Dasatinib, Ifosfamide, Carboplatin, and Etoposide in Treating Young Patients With Metastatic or Recurrent Malignant Solid Tumors
|
Phase 1/Phase 2 | |
| Completed |
NCT03756597 -
PAN-study: Pan-Cancer Early Detection Study (PAN)
|
||
| Recruiting |
NCT05160740 -
Indocyanine Green Molecular Fluorescence Imaging Technique Using in Diagnosis and Treatment of Primary Liver Cancer
|
N/A | |
| Completed |
NCT01906021 -
Study of New Software Used During Ablations
|
N/A | |
| Terminated |
NCT04589884 -
Intraoperative EXamination Using MAChine-learning-based HYperspectral for diagNosis & Autonomous Anatomy Assessment
|
||
| Recruiting |
NCT05953337 -
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)
|
N/A | |
| Enrolling by invitation |
NCT04466124 -
Prospective Cohort Study of Liver Cancer Patients Treated With Proton Beam Therapy
|
||
| Not yet recruiting |
NCT06036563 -
Prospective Screening and Differentiating Common Cancers Using Peripheral Blood Cell-Free DNA Sequencing
|
||
| Not yet recruiting |
NCT04053231 -
Hepatocarcinoma Recurrence on the Liver Study - Part2
|
||
| Active, not recruiting |
NCT02869217 -
Study of TBI-1301 (NY-ESO-1 Specific TCR Gene Transduced Autologous T Lymphocytes) in Patients With Solid Tumors
|
Phase 1 | |
| Completed |
NCT03059238 -
Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure
|
Phase 3 | |
| Recruiting |
NCT02632188 -
Radical Surgery Followed by Immunotherapy Using Precision T Cells Specific to Multiple Common Tumor-Associated Antigen for the Treatment of Hepatocellular Carcinoma
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01388101 -
Real-time Diagnosis of Serum LECT 2 in Patient With Liver Cancer Using Electronic Antibody Sensor (e- Ab Sensor)
|
N/A | |
| Completed |
NCT01042041 -
Sorafenib Tosylate and Chemoembolization in Treating Patients With Unresectable Liver Cancer
|
Phase 1 | |
| Completed |
NCT00980239 -
HAI Irinotecan + IV Bevacizumab, Bevacizumab & Oxaliplatin or Bevacizumab & Cetuximab in Advanced Cancers Metastatic to Liver
|
Phase 1 | |
| Terminated |
NCT00903396 -
Palonosetron Hydrochloride in Preventing Nausea and Vomiting Caused by Radiation Therapy in Patients With Primary Abdominal Cancer
|
Phase 2 | |
| Completed |
NCT00790569 -
Varenicline or Nicotine Patch and Nicotine Gum in Helping Smokers in a Methadone Treatment Program Stop Smoking
|
N/A | |
| Completed |
NCT00543777 -
Magnetic Resonance Elastography and 2-Point Dixon MR Imaging Techniques in Diffuse Liver Disease
|
Phase 1/Phase 2 |