Hepatocellular CancerNCT03474354
DC Bead LUMI (TM) Loaded With Doxorubicin for Intermediate Hepatocellular Carcinoma (HCC)
An observational study of Hepatocellular Cancer and Chemoembolization, run by Malagari Katerina at 1 site in Greece.
Trial summary
The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 88 years
- Conditions the study is for
- Hepatocellular Cancer, Chemoembolization
- What is being tested?
- chemoembolization
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteGreece
- Study dates
- 2 May 2018to 5 Jan 2022
- 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 88 years
- All sexes
- Adult, Older adult
Study population: Patients with intermediate stage hepatocellular carcinoma (BCLC B)
Who may be able to join
- Patient is at least 18 years old.
- HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) criteria.
- Barcelona Criteria Liver Cancer (BCLC) stage B patients or BCLC stage A patients not candidates for curative treatment (resection, transplantation, ablation) or who have failed/recurred after resection/ablation).
- Tumour burden (located in one or two lobes) that can be sufficiently and selectively embolised with required dose or radiopaque bead loaded with doxorubicin.
- Performance status: Eastern Cooperative Oncology Group (ECOG) status 0/1.
- Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh A score and Child/Pugh B≤ 7 points ) without ascites.
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- Total bilirubin ≤2.0 mg/dl.
- Adequate renal function (serum creatinine < 1.5 X ULN).
- Patient has provided written informed consent.
Who cannot join
- Patient previously treated with any intra-arterial therapy for HCC.
- Eligible for curative treatment (resection/RadioFrequency Ablation-RFA, transplantation therapies).
- Advanced liver disease: Child-Pugh's C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels >2.0 mg/dl.
- Advanced tumoural disease: BCLC class C (vascular invasion -even segmental, extra-hepatic spread or cancer-related symptoms=ECOG of 1-2) or D class (WHO performance status 3 or 4, Okuda III stage).
- Patient with another primary tumour.
- Patient with refractory ascites or on diuretic treatment; minor ascites retention detected at imaging and not requiring diuretics to be solved is not a contraindication.
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- Patient with history of biliary tree disease or biliary dilatation.
- Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated.
- Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media).
- Any other contraindication for embolisation or local doxorubicin treatment.
- Patients currently receive treatment with any investigational drug/device/intervention or have received any investigational product within 1 month or 5 half-lives of the investigational agent (whichever is longer) before study treatment.
- In the Investigator's opinion patient has (a) co-morbid condition(s) that could limit the patient's ability to participate in the study, compliance with follow-up requirements or impact the scientific integrity of the study.
- Pregnant or breast-feeding women.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation of Necrosis With DC Bead LUMI (TM) Distribution
The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled.
Read the detailed description
The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled. Primary endpoint : Local response (evaluated with CT and MRI at 4 to 6 weeks post each procedure and at 6 months according to mRECIST) in patients with intermediate-stage HCC following chemoembolisation with radiopaque bead. Secondary endpoints include: 1) Better definition of end point of embolization for drug eluting beads : Ability to achieve near-stasis during chemoembolisation procedure in the tumour feeding vessels using intra-procedural imaging feedback from the radiopaque bead (early visualization of non target embolization 2) Total dose needed for tumor devascularization 3)Distribution of radiopaque beads and correlation with necrosis and adverse events
- Conditions
- Hepatocellular Cancer, Chemoembolization
- Being tested
- chemoembolization
- Keywords
- chemoembolization, drug eluting beads
- Medical subject headings
- Liver Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chemoembolizationDevice
correlation of necrosis with the deposition of beads
What is being measured
The primary outcome is the main question the study is designed to answer.
CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS
Local response following chemoembolisation
Measured: 12 months
Secondary outcomes (3)
Definition of end point of embolization for drug eluting beads
optimization of embolization
Measured: 12 months
Total dose needed for tumor devascularization
dose required for tumor devascularization
Measured: 12 months
Distribution of radiopaque beads and correlation with necrosis
correlation between imaging and tumor necrosis
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study start2 May 2018
- Primary completion5 Jan 2022
- Study completion5 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Malagari Katerina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Malagari Katerina, University of Athens
- Investigators
- KATERINA MALAGARI, Principal investigator, Evgenidion Hospital Athens, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474354
- Sponsor's protocol ID
- IIS_Malagari Athens_BTG
- Status last verified
- Jan 2022
- First submitted
- 13 Feb 2018
- Last updated
- 6 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: CT and MRI images will be stored anonymously by giving each patient a code number
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Necrosis With DC Bead LUMI (TM) Distribution
- ClinicalTrials.gov ID
- NCT03474354
- Acronym / sponsor ID
- IIS_Malagari Athens_BTG
- Conditions
- Hepatocellular Cancer, Chemoembolization
- Keywords
- chemoembolization, drug eluting beads
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Malagari KaterinaUniversity, hospital or other
- Study start
- 2 May 2018 (actual)
- Primary completion
- 5 Jan 2022 (actual)
- Study completion
- 5 Jan 2022 (actual)
- First posted
- 22 Mar 2018 (actual)
- 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 primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled.
Detailed description
The primary purpose of the study is to evaluate the distribution of radiopaque microspheres loaded with doxorubicin in the treatment of unresectable HCC. Prospective, single arm, open label, single centre, pilot study. All patients will undergo clinical follow-up. Twenty patients will be enrolled. Primary endpoint : Local response (evaluated with CT and MRI at 4 to 6 weeks post each procedure and at 6 months according to mRECIST) in patients with intermediate-stage HCC following chemoembolisation with radiopaque bead. Secondary endpoints include: 1) Better definition of end point of embolization for drug eluting beads : Ability to achieve near-stasis during chemoembolisation procedure in the tumour feeding vessels using intra-procedural imaging feedback from the radiopaque bead (early visualization of non target embolization 2) Total dose needed for tumor devascularization 3)Distribution of radiopaque beads and correlation with necrosis and adverse events
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 88 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with intermediate stage hepatocellular carcinoma (BCLC B)
Key inclusion criteria (9 listed)
- Patient is at least 18 years old.
- HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) criteria.
- Barcelona Criteria Liver Cancer (BCLC) stage B patients or BCLC stage A patients not candidates for curative treatment (resection, transplantation, ablation) or who have failed/recurred after resection/ablation).
- Tumour burden (located in one or two lobes) that can be sufficiently and selectively embolised with required dose or radiopaque bead loaded with doxorubicin.
- Performance status: Eastern Cooperative Oncology Group (ECOG) status 0/1.
Key exclusion criteria (13 listed)
- Patient previously treated with any intra-arterial therapy for HCC.
- Eligible for curative treatment (resection/RadioFrequency Ablation-RFA, transplantation therapies).
- Advanced liver disease: Child-Pugh's C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels >2.0 mg/dl.
- Advanced tumoural disease: BCLC class C (vascular invasion -even segmental, extra-hepatic spread or cancer-related symptoms=ECOG of 1-2) or D class (WHO performance status 3 or 4, Okuda III stage).
- Patient with another primary tumour.
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 |
|---|---|---|
| chemoembolizationcorrelation of necrosis with the deposition of beads | Device | – |
Primary outcome
CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS
Time frame: 12 months
Local response following chemoembolisation
3 secondary outcomes
Definition of end point of embolization for drug eluting beads
Time frame: 12 months
Total dose needed for tumor devascularization
Time frame: 12 months
Distribution of radiopaque beads and correlation with necrosis
Time frame: 12 months
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 6 Jan 2022.
- Individual participant dataSharing planned: Yes. CT and MRI images will be stored anonymously by giving each patient a code number
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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.
KATERINA MALAGARI principal investigator
Evgenidion Hospital Athens, Greece
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 Cancer and Chemoembolization, run by Malagari Katerina at 1 site in Greece.
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 9 inclusion and 13 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 6 Jan 2022. 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 Greece. 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?
CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS (time frame: 12 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 6 Jan 2022.