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

NCT01097239 | Withdrawn Phase 1 DMC

• 1 other identifier: 09/H0808/43
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Rectal Cancer; Ovarian Cancer; Endometrial Cancer; Vaginal Cancer; Cervical Cancer

Keywords

High Intensity Focused Ultrasound; HIFU; Rectal Cancer; Sonablate 500; Transrectal

Outcome Measures

Primary Outcomes (1)

• Quality of life scores (EORTC QLQ-C30 and/or EORTC QLQ-CR38, EORTC QLQ-CX24, EORTC QLQ-EN24 or EORTC QLQ-OV24)

  Validated Quality of Life Questionnaire

  Within the first 30, 60 and 90 days after HIFU

Secondary Outcomes (2)

• Pain relief visual analogue scale

  Within the first 30, 60 and 90 days after HIFU

• Tumour marker changes (CEA and CA19.9)

  Within the first 30, 60 and 90 days after HIFU

Study Arms (1)

High Intensity Focused Ultrasound

EXPERIMENTAL

Transrectal High Intensity Focused Ultrasound (HIFU) treatment of the PelvicTumour

Device: Sonablate 500 (High Intensity Focused Ultrasound (HIFU))

Interventions

Sonablate 500 (High Intensity Focused Ultrasound (HIFU)) DEVICE

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

Also known as: Sonablate 500, HIFU

High Intensity Focused Ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (1)

Imperial College Healthcare NHS Trust (Hammersmith Hospital)

London, England, W12 0HS, United Kingdom

Location

Related Publications (16)

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• Visioli AG, Rivens IH, ter Haar GR, Horwich A, Huddart RA, Moskovic E, Padhani A, Glees J. Preliminary results of a phase I dose escalation clinical trial using focused ultrasound in the treatment of localised tumours. Eur J Ultrasound. 1999 Mar;9(1):11-8. doi: 10.1016/s0929-8266(99)00009-9.

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• Wu F, Wang ZB, Chen WZ, Bai J, Zhu H, Qiao TY. Preliminary experience using high intensity focused ultrasound for the treatment of patients with advanced stage renal malignancy. J Urol. 2003 Dec;170(6 Pt 1):2237-40. doi: 10.1097/01.ju.0000097123.34790.70.

  PMID: 14634387 BACKGROUND

• Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54. doi: 10.1067/mob.2003.345.

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  PMID: 14676799 BACKGROUND

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MeSH Terms

Conditions

Rectal Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Vaginal Neoplasms; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Vaginal Diseases; Uterine Cervical Diseases

Study Officials

• Paul D Abel, ChM FRCS(Lon) FRCS(Ed)

  Imperial College London

  PRINCIPAL INVESTIGATOR

• Leonardo Monzon, BSc MBBS MRCS(Eng)

  Imperial College Healthcare NHS Trust

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 1, 2010
• Study Start: November 1, 2009
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

GB (1)