Unresectable Hepatocellular CarcinomaTACENCT02093104
TACE Study-Liver Embolization Perfusion (VGH Radiology LIU)
An observational study of Unresectable Hepatocellular Carcinoma and Undergoing Chemoembolization and Radioembolization, run by University of British Columbia at 1 site in Canada.
Trial summary
The purpose of this research study is to evaluate the quantitative information of utilizing C-arm systems in liver tumor care in hopes this potential clinical combination of imaging could aid in diagnosis and evaluation of tumor therapy. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Unresectable Hepatocellular Carcinoma, Undergoing Chemoembolization and Radioembolization
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with unresectable hepatocellular carcinoma undergoing chemoembolization and radioembolization
Who may be able to join
- Histological or cytological diagnosis or meet the AASLD criteria for diagnosis of hepatocellular carcinoma (HCC) and at least one uni-dimensional lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria by CT-scan
- OR radiologic evidence of liver metastatic disease
- Amenable to embolization or ablation as adjuvant, neoadjuvant or definitive (curative or palliative) therapy.
- Adult > 19 years old and estimated life expectancy over 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status under or equals 1
- Adequate haematological function: Hb over or equals 9g/100mL, absolute neutrophil count over or equals 1 500/mm3, platelet count over or equals 50 000/mm3
Show all 10Show fewer
- Adequate renal function; serum creatinine under 150μmol/L
- Bilirubin under or equals 50 µmol/L, Aspartate aminotransferase (AST) or ALT uner or equals 5 x upper limit of normal (ULN), international normalized ratio (INR) under or equals 1.5
- Liver cirrhosis Child Pugh A - B7
- Ability to provide written informed consent
Who cannot join
- Advanced liver disease with Child-Pugh score over 7 or active gastrointestinal bleeding or encephalopathy or ascites refractory to diuretic therapy
- Women who are pregnant or breast feeding
- Allergy to contrast media
- Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation OR contraindication to locally curative ablation due to size, location or shape.
- Psychiatric or other disorder likely to impact on informed consent
- Patient unable and/or unwilling to comply with treatment and study instructions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utilizing Intraprocedural Flow and Perfusion Dynamics as a Predictor of Response in Patients With Unresectable Hepatocellular Carcinoma Undergoing Chemoembolization and Radioembolization (Y90) "Liver Embolization Perfusion TACE Study (Version 1.0) EPTS 2013-1.0"
The purpose of this research study is to evaluate the quantitative information of utilizing C-arm systems in liver tumor care in hopes this potential clinical combination of imaging could aid in diagnosis and evaluation of tumor therapy.
Read the detailed description
Blood flow imaging for liver tumors is normally carried out using clinical Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) systems prior to going to the cath lab. This study aims to determine if measuring flow using a C-arm system and/or CT perfusion can be used to improve diagnosis and evaluation of liver tumors.
The major difference between C-arm CT systems and clinical CT systems is the difference in imaging speed. We have developed a new approach that should allow us to overcome this speed limitation. The major difference between conventional CT versus CT perfusion is the obtaining of an extra series of images. CT perfusion results in an increase in the amount of radiation exposure during the CT scan that measures the blood flow of the targeted tumor; however, CT perfusion is much faster than conventional CT.
Prospective participants are being invited to the study because part of the treatment towards the tumour therapy involves obtaining an angiogram.
- Keywords
- unresectable hepatocellular carcinoma, (undergoing chemoembolization and radioembolization)
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Tumour Perfusion using CT & C-arm systems in 40 patients at VGH over a 3 month period
The purpose of this protocol is to study the potential predictive and prognostic value of tumor perfusion assessment utilizing computed tomography and C-arm systems in the treatment of liver tumors.
Observational nature of study; post hoc analysis precludes determination of primary endpoint.
3 month follow-up CT scans as per protocol involving standard of care 4 phase CT scan in addition to perfusion CT
Utilizing intraprocedural flow and perfusion dynamics as a predictor of response in 40 patients with unresectable hepatocellular carcinoma undergoing intraprocedural flow and perfusion dynamics as a predictor of response in chemoembolization and radioembolization (Y90)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unresectable Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dave Liu, University of British Columbia
- Investigators
- David MT Liu, MD, Principal investigator, UBC/VCHA/VGH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02093104
- Sponsor's protocol ID
- H12-03704
- Other IDs
- SIEMENS Canada/USA
- Acronym
- TACE
- Status last verified
- May 2017
- First submitted
- 10 Mar 2014
- Last updated
- 8 May 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing Intraprocedural Flow and Perfusion Dynamics as a Predictor of Response in Patients With Unresectable Hepatocellular Carcinoma Undergoing Chemoembolization and Radioembolization (Y90) "Liver Embolization Perfusion TACE Study (Version 1.0) EPTS 2013-1.0"
- ClinicalTrials.gov ID
- NCT02093104
- Acronym / sponsor ID
- TACE / H12-03704
- Keywords
- unresectable hepatocellular carcinoma, (undergoing chemoembolization and radioembolization)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the quantitative information of utilizing C-arm systems in liver tumor care in hopes this potential clinical combination of imaging could aid in diagnosis and evaluation of tumor therapy.
Detailed description
Blood flow imaging for liver tumors is normally carried out using clinical Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) systems prior to going to the cath lab. This study aims to determine if measuring flow using a C-arm system and/or CT perfusion can be used to improve diagnosis and evaluation of liver tumors.
The major difference between C-arm CT systems and clinical CT systems is the difference in imaging speed. We have developed a new approach that should allow us to overcome this speed limitation. The major difference between conventional CT versus CT perfusion is the obtaining of an extra series of images. CT perfusion results in an increase in the amount of radiation exposure during the CT scan that measures the blood flow of the targeted tumor; however, CT perfusion is much faster than conventional CT.
Prospective participants are being invited to the study because part of the treatment towards the tumour therapy involves obtaining an angiogram.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with unresectable hepatocellular carcinoma undergoing chemoembolization and radioembolization
Key inclusion criteria (10 listed)
- Histological or cytological diagnosis or meet the AASLD criteria for diagnosis of hepatocellular carcinoma (HCC) and at least one uni-dimensional lesion measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria by CT-scan
- OR radiologic evidence of liver metastatic disease
- Amenable to embolization or ablation as adjuvant, neoadjuvant or definitive (curative or palliative) therapy.
- Adult > 19 years old and estimated life expectancy over 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status under or equals 1
Key exclusion criteria (6 listed)
- Advanced liver disease with Child-Pugh score over 7 or active gastrointestinal bleeding or encephalopathy or ascites refractory to diuretic therapy
- Women who are pregnant or breast feeding
- Allergy to contrast media
- Contraindication to hepatic artery catheterisation, such as severe peripheral vascular disease precluding catheterisation OR contraindication to locally curative ablation due to size, location or shape.
- Psychiatric or other disorder likely to impact on informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Liver Tumour Perfusion using CT & C-arm systems in 40 patients at VGH over a 3 month period
Time frame: 3 months
The purpose of this protocol is to study the potential predictive and prognostic value of tumor perfusion assessment utilizing computed tomography and C-arm systems in the treatment of liver tumors. Observational nature of study; post hoc analysis precludes determination of primary endpoint. 3 month follow-up CT scans as per protocol involving standard of care 4 phase CT scan in addition to perfusion CT Utilizing intraprocedural flow and perfusion dynamics as a predictor of response in 40 patients with unresectable hepatocellular carcinoma undergoing intraprocedural flow and perfusion dynamics as a predictor of response in chemoembolization and radioembolization (Y90)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
Related trials for Unresectable Hepatocellular Carcinoma
Not yet recruiting
Overcoming Immunotherapy Resistance in Hepatocellular Carcinoma
Hepatocellular Carcinoma Non-Resectable
Active, not recruitingPhase 2
Testing the Combination of Pevonedistat With Chemotherapy for Bile Duct Cancer of the Liver
Metastatic Cholangiocarcinoma, Metastatic Hepatocellular Carcinoma
RecruitingPhase 1/2
A Study to Evaluate the Safety and Tolerability of Pumitamig Alone or In Combination With Ipilimumab in Participants With First-Line Advanced or Unresectable Hepatocellular Carcinoma (HCC) (ROSETTA HCC-206)
Hepatocellular Carcinoma (HCC)
RecruitingPhase 1/2
A Study of TTI-101 as Monotherapy and in Combination in Participants With Locally Advanced or Metastatic, and Unresectable Hepatocellular Carcinoma
Hepatocellular Carcinoma
RecruitingPhase 1
A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver Cancer
Hepatocellular Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David MT Liu, MD principal investigator
UBC/VCHA/VGH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unresectable Hepatocellular Carcinoma and Undergoing Chemoembolization and Radioembolization, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver Tumour Perfusion using CT & C-arm systems in 40 patients at VGH over a 3 month period (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017.