NCT03595722

Exploring HIFU as a Treatment for Rectal and Other Pelvic Cancers

Status unknown NA Last updated 15 August 2019

What this trial tests

NA trial testing High Intensity Focused Ultrasound in Rectal Cancer in 60 participants. Status unknown.

Timeline

11 July 2019

Primary endpoint
28 August 2022

28 August 2022

Quick facts

Lead sponsor	Imperial College London
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	60
Start date	11 July 2019
Primary completion	28 August 2022
Estimated completion	28 August 2022
Sites	1 location across United Kingdom

Drugs / interventions tested

• High Intensity Focused Ultrasound

Conditions studied

• Rectal Cancer — all drugs for Rectal Cancer →
• Rectal Neoplasms — all drugs for Rectal Neoplasms →
• Pelvic Cancer — all drugs for Pelvic Cancer →
• Endometrial Cancer — all drugs for Endometrial Cancer →

Sponsor

Imperial College London

Who can join

Adults 18 to 90, any sex, with Rectal Cancer or Rectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The hypothesis of the study is that high intensity focused ultrasound (HIFU) can be used safely to treat rectal and pelvic cancer. The study consists of two trials exploring the use of HIFU in rectal and pelvic cancer to establish the safety and potential efficacy of HIFU in this instance.

The first trial is a feasibility study looking at patients with early rectal cancer. We aim to recruit thirty patients with early rectal cancer who are due to undergo an operation to remove their cancer. After recruiting and consenting them for the trial, we will treat their rectal cancer with HIFU. Approximately one week after treatment they will undergo their normal cancer operation. This will allow us to demonstrate the safety of HIFU as a treatment for rectal cancer and evaluate the changes in rectal and surrounding tissue under the microscope after the cancer is treated with HIFU. In addition, we will monitor patients for any complications and the impact this treatment has on their quality of life. We will monitor the response of various markers for cancer with blood tests.

The second trial aims to evaluate the treatment of a cohort of patients with inoperable rectal cancer. We aim to recruit thirty patients with either inoperable pelvic cancers - rectal, cervical or endometrial, or cancers that have returned after previous operations. We will offer these patients treatment of their cancer using HIFU. We will monitor the symptoms they experience and impact on their quality of life both before and at multiple time points after the treatment with HIFU. We will compare MRI scans before and after treatment to evaluate the effect HIFU has in reducing the size of the cancer. We hope to show that using HIFU in this group of patients can be both effective and lead to an improvement in both their symptoms and quality of life.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Immunomodulation and targeted drug delivery with high intensity focused ultrasound (HIFU): Principles and mechanisms.
   Ashar H, Ranjan A. · · 2023 · cited 41× · PMID 36965581 · DOI 10.1016/j.pharmthera.2023.108393