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

Sponsor

Malagari Katerina (Other)

Overall Status

Completed

CT.gov ID

NCT03474354

Collaborator

(none)

Enrollment

Location

44.2

Actual Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Cancer Chemoembolization	Device: chemoembolization

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

Study Type:

Observational

Actual Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Correlation of Necrosis With DC Bead LUMI (TM) Distribution

Actual Study Start Date :

May 2, 2018

Actual Primary Completion Date :

Jan 5, 2022

Actual Study Completion Date :

Jan 5, 2022

Outcome Measures

Primary Outcome Measures

CORRELATION OF LUMI DISTRIBUTION WITH NECROSIS [12 months]
Local response following chemoembolisation

Secondary Outcome Measures

Definition of end point of embolization for drug eluting beads [12 months]
optimization of embolization
Total dose needed for tumor devascularization [12 months]
dose required for tumor devascularization
Distribution of radiopaque beads and correlation with necrosis [12 months]
correlation between imaging and tumor necrosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 88 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

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.
Total bilirubin ≤2.0 mg/dl.
Adequate renal function (serum creatinine < 1.5 X ULN).
Patient has provided written informed consent.

Exclusion Criteria:

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.
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Evgenidion Hospital	Athens	Attiki	Greece	15538

Sponsors and Collaborators

Malagari Katerina

Investigators

Principal Investigator: KATERINA MALAGARI, EVGENIDION HOSPITAL, ATHENS, GREECE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Malagari Katerina, ASSOCIATE PROFESSOR, University of Athens

ClinicalTrials.gov Identifier:

NCT03474354

Other Study ID Numbers:

IIS_Malagari Athens_BTG

First Posted:

Mar 22, 2018

Last Update Posted:

Jan 6, 2022

Last Verified:

Jan 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Malagari Katerina, ASSOCIATE PROFESSOR, University of Athens

chemoembolization

drug eluting beads

Additional relevant MeSH terms:

Liver Neoplasms

Carcinoma, Hepatocellular

Study Results

No Results Posted as of Jan 6, 2022