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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Imperial College London
Sponsor:
Collaborator:
Imperial College Healthcare NHS Trust
Information provided by (Responsible Party):
Imperial College London
ClinicalTrials.gov Identifier:
NCT01097239
First received: March 31, 2010
Last updated: February 16, 2016
Last verified: January 2016
  Purpose

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.


Condition Intervention Phase
Rectal Cancer
Ovarian Cancer
Endometrial Cancer
Vaginal Cancer
Cervical Cancer
Device: Sonablate 500 (High Intensity Focused Ultrasound (HIFU))
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Phase I/II Feasibility/Efficacy Study of HIFU in Otherwise Untreatable Pelvic Rectal Cancer

Resource links provided by NLM:


Further study details as provided by Imperial College London:

Primary Outcome Measures:
  • Quality of life scores (EORTC QLQ−C30 and/or EORTC QLQ−CR38, EORTC QLQ-CX24, EORTC QLQ-EN24 or EORTC QLQ-OV24) [ Time Frame: Within the first 30, 60 and 90 days after HIFU ] [ Designated as safety issue: No ]
    Validated Quality of Life Questionnaire


Secondary Outcome Measures:
  • Pain relief visual analogue scale [ Time Frame: Within the first 30, 60 and 90 days after HIFU ] [ Designated as safety issue: No ]
  • Tumour marker changes (CEA and CA19.9) [ Time Frame: Within the first 30, 60 and 90 days after HIFU ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: November 2009
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High Intensity Focused Ultrasound
Transrectal High Intensity Focused Ultrasound (HIFU) treatment of the PelvicTumour
Device: Sonablate 500 (High Intensity Focused Ultrasound (HIFU))
High Intensity Focused Ultrasound (HIFU) Delivered by the Sonablate 500 Transrectal Device
Other Names:
  • Sonablate 500
  • HIFU

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Biopsy proven rectal, vaginal, ovarian, endometrial or cervical cancer (tumour <15cm from anal/vaginal verge)
  • Lymph node(s) accessible by HIFU for which the primary clinical team advise intervention
  • Partially fixed/unresectable disease and locally advanced disease (T3/T4)
  • Patient considered to be unsuitable for or have exhausted all currently available therapies
  • WHO Performance Status 0-2
  • Fit for general anaesthetic and HIFU
  • Not pregnant
  • No other serious uncontrolled concomitant illness likely to interfere with treatment or assessment
  • Written informed consent for treatment

Exclusion Criteria:

  • WHO performance status of 3 or more
  • Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude anaesthetic or informed consent
  • Pelvic sepsis
  • Currently enrolled in any other treatment trial
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01097239

Contacts
Contact: Paul D Abel, ChM FRCS(Lon) FRCS(Ed) +44208 383 2268 p.abel@imperial.ac.uk
Contact: Leonardo Monzon, BSc MBBS MRCS(Eng) +447932043627 leonardomonzonrodriguez@googlemail.com

Locations
United Kingdom
Imperial College Healthcare NHS Trust (Hammersmith Hospital) Recruiting
London, England, United Kingdom, W12 0HS
Contact: Paul D Abel, ChM FRCS(Lon) FRCS(Ed)    +44208 383 2268    p.abel@imperial.ac.uk   
Contact: Leonardo Monzon, BSc MBBS MRCS(Eng)    +447932043627    leonardomonzonrodriguez@googlemail.com   
Principal Investigator: Paul D Abel, ChM FRCS(Lon) FRCS(Ed)         
Sub-Investigator: Edward Leen, MD FRCR         
Sub-Investigator: Peter Dawson, FRCS         
Sub-Investigator: Chris Harvey, FRCR         
Sub-Investigator: Harpreet Wasan, MBBS MRCP         
Sub-Investigator: Hashim U Ahmed, MRCS         
Sub-Investigator: Leonardo Monzon, BSc MBBS MRCS(Eng)         
Sponsors and Collaborators
Imperial College London
Imperial College Healthcare NHS Trust
Investigators
Principal Investigator: Paul D Abel, ChM FRCS(Lon) FRCS(Ed) Imperial College London
Study Chair: Leonardo Monzon, BSc MBBS MRCS(Eng) Imperial College Healthcare NHS Trust
  More Information

Additional Information:
Publications:

Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT01097239     History of Changes
Other Study ID Numbers: 09/H0808/43 
Study First Received: March 31, 2010
Last Updated: February 16, 2016
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Imperial College London:
High Intensity Focused Ultrasound
HIFU
Rectal Cancer
Sonablate 500
Transrectal

Additional relevant MeSH terms:
Rectal Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Vaginal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vaginal Diseases

ClinicalTrials.gov processed this record on July 24, 2016