Clinical trial · Interventional
Examining the Role of Transrectal High Intensity Focused Ultrasound (HIFU) in Rectal Pelvic Cancer
A Phase I/II Feasibility/Efficacy Study of HIFU in Otherwise Untreatable Pelvic Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Failure to recruit.
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Vaginal Cancer | Malignant Vaginal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sonablate 500 (High Intensity Focused Ultrasound (HIFU)) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- High Intensity Focused Ultrasound
- description
- Transrectal High Intensity Focused Ultrasound (HIFU) treatment of the PelvicTumour
- interventionNames
- Device: Sonablate 500 (High Intensity Focused Ultrasound (HIFU))
Primary outcomes (1)
- measure
- Quality of life scores (EORTC QLQ-C30 and/or EORTC QLQ-CR38, EORTC QLQ-CX24, EORTC QLQ-EN24 or EORTC QLQ-OV24)
- timeFrame
- Within the first 30, 60 and 90 days after HIFU
- description
- Validated Quality of Life Questionnaire
Secondary outcomes (2)
- measure
- Pain relief visual analogue scale
- timeFrame
- Within the first 30, 60 and 90 days after HIFU
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (16)
- BACKGROUNDThuroff S, Chaussy C, Vallancien G, Wieland W, Kiel HJ, Le Duc A, Desgrandchamps F, De La Rosette JJ, Gelet A. High-intensity focused ultrasound and localized prostate cancer: efficacy results from the European multicentric study. J Endourol. 2003 Oct;17(8):673-7. doi: 10.1089/089277903322518699. PMID 14622488
- BACKGROUNDHill CR, ter Haar GR. Review article: high intensity focused ultrasound--potential for cancer treatment. Br J Radiol. 1995 Dec;68(816):1296-1303. doi: 10.1259/0007-1285-68-816-1296. PMID 8777589
- BACKGROUNDThuroff S, Chaussy C. High-intensity focused ultrasound: complications and adverse events. Mol Urol. 2000 Fall;4(3):183-7;discussion 189. PMID 11062373
- BACKGROUNDVisioli 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. PMID 10099162
- BACKGROUNDWu F, Chen WZ, Bai J, Zou JZ, Wang ZL, Zhu H, Wang ZB. Pathological changes in human malignant carcinoma treated with high-intensity focused ultrasound. Ultrasound Med Biol. 2001 Aug;27(8):1099-106. doi: 10.1016/s0301-5629(01)00389-1. PMID 11527596
- BACKGROUNDWu 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
- BACKGROUNDStewart 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.