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Examining the Role of Transrectal High Intensity Focused Ultrasound (HIFU) in Rectal Pelvic Cancer

NCT01097239 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2020-11-20

No results posted yet for this study

Summary

This is a single centre pilot trial to establish the feasibility and role of endoluminal HIFU in patients with locally advanced cancer within the pelvis that is either primary or recurrent and with all available current therapy inappropriate and/or exhausted.

The aim is to make a preliminary assessment of efficacy \& dosage for evaluation in a randomised controlled trial. Whilst efficacy data are limited in a small feasibility study; radiological, biochemical and histopathological analysis of the patient and patient specimens, along with quality of life questionnaires (QoL), will be used to provide preliminary measures of efficacy in this patient cohort.

These analyses will allow examination of the biochemical, metabolomic and histological changes associated with HIFU treatment in cancer within the pelvis.

Conditions

Interventions

DEVICE

Sonablate 500 (High Intensity Focused Ultrasound (HIFU))

High Intensity Focused Ultrasound (HIFU) Delivered by the Sonablate 500 Transrectal Device

Sponsors & Collaborators

  • Imperial College Healthcare NHS Trust

    collaborator OTHER

  • Imperial College London

    lead OTHER

Principal Investigators

  • Paul D Abel, ChM FRCS(Lon) FRCS(Ed) · Imperial College London

  • Leonardo Monzon, BSc MBBS MRCS(Eng) · Imperial College Healthcare NHS Trust

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2018-09-30
Completion
2018-09-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT01097239 on ClinicalTrials.gov