NCT01126463

Brief Summary

This study is to determine the maximum tolerated dose and the recommended 188Re-SSS Lipiodol activity for hepatic intra-arterial injection in patients with hepato-cellular carcinoma. The new radioactive isotope 188Rhenium associated with Lipiodol is expected to reduce the radioprotection constraints and hence the duration of the hospitalisation in a protected room from 8 to 1 day.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2010

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 19, 2010

Completed
7 days until next milestone

Study Start

First participant enrolled

May 26, 2010

Completed
9.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2019

Completed
Last Updated

August 2, 2021

Status Verified

July 1, 2020

Enrollment Period

9.2 years

First QC Date

May 18, 2010

Last Update Submit

July 26, 2021

Conditions

Hepatocellular Carcinomas

Keywords

Hepatocellular carcinomaslipiodolrheniumNon operable Hepatocellular carcinomas

Outcome Measures

Primary Outcomes (1)

  • Maximal tolerated dose

    Toxicity CTC grade ≥ 3 with CTCAE version 4.

    Injection each week during 4 weeks and at month 2

Secondary Outcomes (1)

  • Bio-availability

    1, 6, 24 et 48 hours after treatment injection

Study Arms (1)

Rhenium Lipiodol

EXPERIMENTAL

Hepatic Intra-Arterial Administration of radio-active lipiodol.

Drug: 188Re-SSS Lipiodol

Interventions

188Re-SSS LipiodolDRUG

Hepatic Intra-Arterial Administration of radio-active lipiodol.

Rhenium Lipiodol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult over 18,
  • WHO performance status ≤ 2,
  • Hepatocellular carcinoma histologically or cytologically proven, or association of liver tumor with chronic hepatopathy and AFP \> 400 ng/ml, or tumorous hepatic formation considered as hypervascularised by at least 2 methods of imaging in cirrhotic patient, Non operable, non resectable, non transplantable, non accessible to percutaneous treatment tumor,
  • Measurable tumor, uni- or multinodular, taking up less than 50% of hepatic volume,
  • Stage A to C of the BCLC classification (or stage 0 to 4 of the CLIP) with:
  • No thrombosis of the portal vein, therapeutic escape or intolerance causing the end of the treatment or contraindication to sorafenib
  • If thrombosis of the portal vein, therapeutic escape to Lipiocis,
  • Possibility of treatment by intra-arterial radiotherapy over a decision of a Multidisciplinary Committee,
  • Written informed consent

You may not qualify if:

  • Patient with a stage ≥ 3 toxicity of the CTCAE version 4
  • Stage D of the classification BCLC
  • Acute impairment of hepatic functions (Child-Pugh B9 or C)
  • Grade III Hepatocarcinoma of the Okuda classification
  • Encephalopathy with troubles even moderated of cognitive functions
  • Advanced chronic respiratory insufficiency
  • Creatinine clearance \< 55 ml/min, polynuclear neutrophils \< 1500 G/L, platelets \< 50 G/L, prothrombin \< 40% (INR \> 2,3)
  • Contraindication to the intra-arterial administration
  • Patients who can't be followed up for psychological or geographic reasons
  • Patients dependant on another person for daily care
  • Urinary incontinence
  • Progressive cancer
  • Pregnant or breastfeeding woman, or not using adequate effective contraception method

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Eugene Marquis

Rennes, 35000, France

Location

Related Publications (1)

  • Garin E, Rakotonirina H, Lejeune F, Denizot B, Roux J, Noiret N, Mesbah H, Herry JY, Bourguet P, Lejeune JJ. Effect of a 188 Re-SSS lipiodol/131I-lipiodol mixture, 188 Re-SSS lipiodol alone or 131I-lipiodol alone on the survival of rats with hepatocellular carcinoma. Nucl Med Commun. 2006 Apr;27(4):363-9. doi: 10.1097/00006231-200604000-00008.

    PMID: 16531923BACKGROUND

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

rhenium-SSS-lipiodol

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Etienne GARIN, MD, PhD

    Centre Eugene Marquis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 18, 2010

First Posted

May 19, 2010

Study Start

May 26, 2010

Primary Completion

August 6, 2019

Study Completion

August 6, 2019

Last Updated

August 2, 2021

Record last verified: 2020-07

Locations

FR(1)