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CompletedNCT03474354Updated Jan 6, 2022

DC Bead LUMI (TM) Loaded With Doxorubicin for Intermediate Hepatocellular Carcinoma (HCC)

An observational study in Hepatocellular Cancer and Chemoembolization, sponsored by Malagari Katerina. Completed at 1 site in Greece. Open to participants aged 18 Years to 88 Years. Per ClinicalTrials.gov, last updated 2022-01-06.

Sponsored by Malagari Katerina · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 88 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Hepatocellular Cancer
  • Chemoembolization

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Keywords

  • chemoembolization
  • drug eluting beads
03

In context

Liver Neoplasms

1,406 studies on the registry are indexed under Liver Neoplasms; 347 are open to participants now.

This study's enrollment of 50 is below the median of 200 across 357 observational studies indexed under Liver Neoplasms.

Browse Liver Neoplasms studies →

Lead sponsor

This is the only study on the registry with Malagari Katerina as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 88 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Patients with intermediate stage hepatocellular carcinoma (BCLC B)

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patient is at least 18 years old.
  2. HCC diagnosed according to updated American Association for the Study of Liver Diseases (AASLD) criteria.
  3. 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).
  4. Tumour burden (located in one or two lobes) that can be sufficiently and selectively embolised with required dose or radiopaque bead loaded with doxorubicin.
  5. Performance status: Eastern Cooperative Oncology Group (ECOG) status 0/1.
  6. Normal liver or compensated cirrhosis with preserved liver function (Child-Pugh A score and Child/Pugh B≤ 7 points ) without ascites.
  7. Total bilirubin ≤2.0 mg/dl.
  8. Adequate renal function (serum creatinine \< 1.5 X ULN).
  9. Patient has provided written informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patient previously treated with any intra-arterial therapy for HCC.
  2. Eligible for curative treatment (resection/RadioFrequency Ablation-RFA, transplantation therapies).
  3. Advanced liver disease: Child-Pugh's C class or active gastrointestinal bleeding, encephalopathy. Bilirubin levels >2.0 mg/dl.
  4. 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).
  5. Patient with another primary tumour.
  6. 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.
  7. Patient with history of biliary tree disease or biliary dilatation.
  8. Portal vein thrombosis, porto-systemic shunt, hepatofugal blood flow or absent portal blood flow in the liver area to be treated.
  9. Contraindication to multiphasic CT and MRI (e.g. allergy to contrast media).
  10. Any other contraindication for embolisation or local doxorubicin treatment.
  11. 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.
  12. 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.
  13. Pregnant or breast-feeding women.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)
Patient registry
No

Interventions

  • Devicechemoembolization

    correlation of necrosis with the deposition of beads

06

What researchers measure

Primary outcomes

  1. CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS

    Local response following chemoembolisation

    Time frame: 12 months

Secondary outcomes

  1. Definition of end point of embolization for drug eluting beads

    optimization of embolization

    Time frame: 12 months

  2. Total dose needed for tumor devascularization

    dose required for tumor devascularization

    Time frame: 12 months

  3. Distribution of radiopaque beads and correlation with necrosis

    correlation between imaging and tumor necrosis

    Time frame: 12 months

07

Study locations

1 site
  • Evgenidion Hospital
    Athens, Attica 15538, Greece
08

References and documents

Individual participant data

Plan to share: Yes — CT and MRI images will be stored anonymously by giving each patient a code number

Supporting information: Clinical study report

Time frame: starting February 2018 and ending February 2019

Access criteria: the principal investigator and collaborator will record and analyse data from the CT and MRI of the patients. The names of the patients will not be in the examinations and identity will be given by enrollment number

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from May 2018 to primary completion in Jan 2022, 44 months.

Of 134 non-industry observational studies under Liver Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 193. This study's 44 months is below that.

Counting every sponsor, half of 154 studies reached it within 56 months; a quarter within 34 and three quarters within 193.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 13, 2018
First posted
Mar 22, 2018
StartActual
May 2, 2018
Primary completionActual
Jan 5, 2022
CompletionActual
Jan 5, 2022
Last update
Jan 6, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 6, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03474354
Lead sponsor
Malagari Katerina
Responsible party
Malagari Katerina (ASSOCIATE PROFESSOR, University of Athens) — Sponsor-investigator
First posted
Mar 22, 2018
Start date
May 2, 2018
Primary completion
Jan 5, 2022
Completion
Jan 5, 2022
Last update
Jan 6, 2022

Study contacts

KATERINA MALAGARI
principal investigator · Evgenidion Hospital Athens, Greece

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.

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