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Targeted Chemotherapy Using Focused Ultrasound for Liver Tumours

NCT02181075 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-07-22

Study results available
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Summary

This proof of concept study proposes targeted delivery of a broad-spectrum cytotoxic agent (doxorubicin), via a specially formulated LTSL (ThermoDox®) activated by mild hyperthermia, by using focused ultrasound (FUS), to achieve enhanced intra-tumoural doxorubicin concentrations for the same systemic dose.

Adult patients with incurable confirmed hepatic primary or secondary tumours received a single cycle of LTLD, followed by ultrasound-mediated hyperthermia to a single target liver tumour. The primary endpoint relates to evidencing enhanced delivery of doxorubicin from LTLD at the target tumour site, by comparing intratumoural concentrations of the drug before and after focused ultrasound (FUS) exposure.

Conditions

  • Liver Tumour

Interventions

DRUG

ThermoDox® (LTLD)

ThermoDox® (LTLD) infusion at a dose of 50mg/m2 whilst under general anaesthetic during intervention (Day 1)

DEVICE

Focused Ultrasound of Target Liver Tumour

Whilst the ThermoDox® was circulating in the blood stream, the JC200 Therapeutic Ultrasound device was used to induce mild hyperthermia in a single (region of) a target liver tumour.

DIAGNOSTIC_TEST

Pre-LTLD Biopsy of Target Liver Tumour

DIAGNOSTIC_TEST

Post-LTLD Biopsy of Target Liver Tumour

DIAGNOSTIC_TEST

Post-LTLD+FUS (Post-FUS) Biopsy of Target Liver Tumour

DEVICE

Thermometry of Target Tumour

A clinically approved thermistor or thermocouple was placed in the target liver tumour for real-time thermometry.

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    collaborator OTHER

  • Imunon

    collaborator INDUSTRY

  • University of Oxford

    lead OTHER

Principal Investigators

  • Mark R Middleton, PhD, FRCP · University of Oxford

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2017-03-31
Completion
2017-04-30

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02181075 on ClinicalTrials.gov