Examining the Role of Transrectal High Intensity Focused Ultrasound (HIFU) in Rectal Pelvic Cancer
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|ClinicalTrials.gov Identifier: NCT01097239|
Recruitment Status : Withdrawn (Failure to recruit.)
First Posted : April 1, 2010
Last Update Posted : November 20, 2020
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 or disease||Intervention/treatment||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 (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Phase I/II Feasibility/Efficacy Study of HIFU in Otherwise Untreatable Pelvic Rectal Cancer|
|Actual Study Start Date :||November 2009|
|Actual Primary Completion Date :||September 2018|
|Actual Study Completion Date :||September 2018|
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
- 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 ]Validated Quality of Life Questionnaire
- Pain relief visual analogue scale [ Time Frame: Within the first 30, 60 and 90 days after HIFU ]
- Tumour marker changes (CEA and CA19.9) [ Time Frame: Within the first 30, 60 and 90 days after HIFU ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01097239
|Imperial College Healthcare NHS Trust (Hammersmith Hospital)|
|London, England, United Kingdom, W12 0HS|
|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|