Hepatocellular Carcinoma (HCC)NCT02173119
Can Quantitative MRI After cTACE Help Predict Survival ?
An observational study of Hepatocellular Carcinoma (HCC), run by Medical College of Wisconsin at 1 site in United States.
Trial summary
Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for the treatment of HCC. Palliative means that it does not cure the disease prolongs your life and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with an oil called lipiodol. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hepatocellular Carcinoma (HCC)
- What is being tested?
- MRI post-TACE
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2014to 7 Mar 2018
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with hepatocellular carcinoma (HCC or cancer of the liver) and will soon undergo one or more transcatheter arterial chemoembolization (TACE) procedure(s).
Who may be able to join
- Prospective studies will be performed in 20 patients with Hepatocellular Carcinoma (HCC) independently scheduled to undergo TACE; tumors in each of these candidates will already have been deemed un-resectable.
- Reasons may include
- concurrent co-morbidities including cardiac or respiratory compromise
- recurrent or multi-lobar disease
- cirrhosis or portal hypertension
- vascular invasion
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- high tumor burden
- contraindications to general anesthesia.
- Diagnosis of HCC will have been established by a) biopsy or b) non-invasively, based upon > 2cm diameter tumor with characteristic imaging findings in the setting of cirrhosis.
- Male or female aged 18 to 89 years, all ethnicities
Who cannot join
- Infiltrative or diffuse HCC.
- Does not meet inclusion criteria.
- Pregnant women.
- Individuals with pacemakers or other non-MRI compatible metallic implants.
- Hemodialysis patients or patients with severely impaired renal function.
- Individuals with severe claustrophobia or unwilling to get a MRI.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, 53226
About this study
Official title: Can Quantitative MRI After Conventional Transarterial Chemoembolization (cTACE) Help Predict Survival ?
Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for the treatment of HCC. Palliative means that it does not cure the disease prolongs your life and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected into an artery (blood vessel) directly supplying blood to a HCC tumor.
Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to quantify the amount of lipiodol delivered to the HCC tumors.
In this study, the investigators want to see if patient survival is related to the amount of lipiodol delivered to HCC tumors.
- Conditions
- Hepatocellular Carcinoma (HCC)
- Being tested
- MRI post-TACE
- Keywords
- Hepatocellular, Carcinoma, HCC, lipiodol
- Medical subject headings
- Carcinoma, Hepatocellular, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI post-TACEOther
Perform lipiodol delivery measurements with MRI post-TACE.
| Study group | Role | What they receive |
|---|---|---|
| HCC patients having MRI post-TACE | HCC patients who have undergone conventional lipiodol based chemoembolization. Receives: Other: MRI post-TACE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Imaging response
Imaging response will be assessed according to 3D European Association for the Study of the Liver (EASL) criteria. EASL criteria propose using contrast enhanced (CE) images to measure viable volumes. We will transfer all images to a computer workstation. We will measure 'viable' enhancing tumor volumes at each interval and percent change in viable tumor volume (change from baseline). We will correlate lipiodol delivery measurements to primary outcomes post-therapy.
Measured: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Secondary outcomes (4)
Clinical response
Clinical response will be measured using Eastern Cooperative Oncology Group (ECOG) performance status classification. We will consider a change of 0.5 ECOG levels to be clinically significant.
Measured: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Adverse Events
Adverse Events will be measured according to the Common Terminology Criteria (NCI CTC) version 3.0 criteria for each patient. We will define Grades 0-2 as tolerance to therapy and Grades 3 or 4 as toxic.
Measured: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Time-to-Tumor Progression
Time-to-tumor progression will be assessed by monitoring viable tumor volumes post-TACE and defining progression as a >44% volume increase (3D EASL criteria).
Measured: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Survival
We will determine the number of days from first treatment to last follow-up to calculate the median days of overall survival after first treatment.
Measured: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startAug 2014
- Primary completion7 Mar 2018
- Study completion7 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular Carcinoma (HCC)Studies of the same condition, open and under way.
- More trials run by Medical College of WisconsinThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical College of Wisconsin
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet, Northwestern University
- Responsible party
- Principal investigator, Sarah B. White, Medical College of Wisconsin
- Investigators
- Sarah B. White, MD, Principal investigator, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173119
- Sponsor's protocol ID
- PRO22746
- Status last verified
- Jun 2019
- First submitted
- 17 Jun 2014
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gordon AC, Lewandowski RJ, Li W, Zhong X, Kannengiesser SAR, Miller FH, Salem R, Rilling WS, Larson AC, White SB. Chemical Shift MRI Monitoring of Chemoembolization Delivery for Hepatocellular Carcinoma: Multicenter Feasibility of Initial Clinical Translation. Radiol Imaging Cancer. 2023 May;5(3):e220019. doi: 10.1148/rycan.220019.
PubMed 37233207
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Quantitative MRI After Conventional Transarterial Chemoembolization (cTACE) Help Predict Survival ?
- ClinicalTrials.gov ID
- NCT02173119
- Acronym / sponsor ID
- PRO22746
- Conditions
- Hepatocellular Carcinoma (HCC)
- Keywords
- Hepatocellular, Carcinoma, HCC, lipiodol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Medical College of WisconsinUniversity, hospital or other
- Collaborators
- Guerbet, Northwestern University
- Study start
- Aug 2014
- Primary completion
- 7 Mar 2018 (actual)
- Study completion
- 7 Mar 2018 (actual)
- First posted
- 24 Jun 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.
Transcatheter arterial chemoembolization (TACE) is a widely accepted palliative therapy for the treatment of HCC. Palliative means that it does not cure the disease prolongs your life and improves quality of life. During TACE, a mixture of chemotherapy drugs is combined with an oil called lipiodol. Lipiodol has a role as both drug carrier and embolic agent (a material that blocks blood flow to tumors). The lipiodol/chemotherapy mixture is injected into an artery (blood vessel) directly supplying blood to a HCC tumor.
Lipiodol is made up of fat and water which can be seen on MRI. Therefore, MRI can be used to quantify the amount of lipiodol delivered to the HCC tumors.
In this study, the investigators want to see if patient survival is related to the amount of lipiodol delivered to HCC tumors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCC patients having MRI post-TACE | – | Other: MRI post-TACEHCC patients who have undergone conventional lipiodol based chemoembolization. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma (HCC or cancer of the liver) and will soon undergo one or more transcatheter arterial chemoembolization (TACE) procedure(s).
Key inclusion criteria (10 listed)
- Prospective studies will be performed in 20 patients with Hepatocellular Carcinoma (HCC) independently scheduled to undergo TACE; tumors in each of these candidates will already have been deemed un-resectable.
- Reasons may include
- Diagnosis of HCC will have been established by a) biopsy or b) non-invasively, based upon > 2cm diameter tumor with characteristic imaging findings in the setting of cirrhosis.
- Male or female aged 18 to 89 years, all ethnicities
Key exclusion criteria (6 listed)
- Infiltrative or diffuse HCC.
- Does not meet inclusion criteria.
- Pregnant women.
- Individuals with pacemakers or other non-MRI compatible metallic implants.
- Hemodialysis patients or patients with severely impaired renal function.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI post-TACEPerform lipiodol delivery measurements with MRI post-TACE. | Other | HCC patients having MRI post-TACE |
Primary outcome
Imaging response
Time frame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Imaging response will be assessed according to 3D European Association for the Study of the Liver (EASL) criteria. EASL criteria propose using contrast enhanced (CE) images to measure viable volumes. We will transfer all images to a computer workstation. We will measure 'viable' enhancing tumor volumes at each interval and percent change in viable tumor volume (change from baseline). We will correlate lipiodol delivery measurements to primary outcomes post-therapy.
4 secondary outcomes
Clinical response
Time frame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Adverse Events
Time frame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Time-to-Tumor Progression
Time frame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
Survival
Time frame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.
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 10 Jun 2019.
- Derived from this study: PubMed 37233207Gordon AC, Lewandowski RJ, Li W, Zhong X, Kannengiesser SAR, Miller FH, Salem R, Rilling WS, Larson AC, White SB. Chemical Shift MRI Monitoring of Chemoembolization Delivery for Hepatocellular Carcinoma: Multicenter Feasibility of Initial Clinical Translation. Radiol Imaging Cancer. 2023 May;5(3):e220019. doi: 10.1148/rycan.220019.
- Individual participant dataSharing planned: No
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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.
Sarah B. White, MD principal investigator
Medical College of Wisconsin
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 Hepatocellular Carcinoma (HCC), run by Medical College of Wisconsin at 1 site in United States.
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 10 Jun 2019. 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 United States. 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?
Imaging response (time frame: Every 4-6 weeks during active treatment and then every 3-6 months, up to 5 years or death.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02173119, which also lists 1 linked publication.
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 10 Jun 2019.