Exploring HIFU as a Treatment for Rectal and Other Pelvic Cancers

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.

Sex

All

Minimum age

18 Years

Maximum age

90 Years

Inclusion Criteria:

Early rectal cancer arm:

1. Biopsy proven rectal cancer \<15cm from anal verge
2. Targeted region ≤ 3cm in depth dimension, deepest region of tumour ≤ 3.5cm from organ/tissue surface accessible by the probe
3. Tumour accessible by the HIFU probe via suitable acoustic window
4. Early stage disease not requiring neo-adjuvant chemo radiotherapy prior to TME - T1/T2 but confirmed to require adjuvant chemotherapy
5. Ability to undergo an intraluminal ultrasound examination
6. World Health Organisation (WHO) Performance Status 0-3
7. Age ≥18 and fit for general anaesthetic and HIFU
8. For women of child bearing potential, not pregnant
9. No other serious uncontrolled concomitant illness likely to interfere with treatment or assessment
10. Written informed consent for treatment

Late pelvic cancer arm:

1. Biopsy proven rectal, vaginal, endometrial or cervical cancer (tumour \<15cm from anal/vaginal verge)
2. Solid tumour/mass ≤ 3cm in depth dimension, deepest region of tumour ≤ 3.5cm from organ/tissue surface accessible by the probe
3. Lymph node(s) accessible by HIFU for which the primary clinical team advise intervention
4. Tumour accessible by the HIFU probe via suitable acoustic window
5. Partially fixed/unresectable disease and locally advanced disease (T3/T4)
6. Ability to undergo an intraluminal ultrasound examination
7. WHO Performance Status 0-3
8. Age ≥18 and fit for general anaesthetic and HIFU
9. For women of child bearing potential, not pregnant
10. No other serious uncontrolled concomitant illness likely to interfere with treatment or assessment
11. Written informed consent for treatment

Exclusion Criteria:

Early rectal cancer arm:

1. WHO performance status of 4
2. Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude anaesthetic or informed consent
3. Pelvic sepsis
4. Currently enrolled in any neo-adjuvant treatment trial that may induce tumour regression
5. Locally advanced disease - T3/T4 or patients who are not thought to require adjuvant therapy
6. Tumours above peritoneal reflection or below dentate line
7. Subjects with tumours lying \< 1cm from sensitive structures/organs

Late pelvic cancer arm:

1. WHO performance status of 4
2. Uncontrolled cardiac, respiratory or other disease, or any serious medical or psychiatric disorder that would preclude anaesthetic or informed consent
3. Pelvic sepsis
4. Currently enrolled in any other palliative treatment trial that may confound results
5. Subjects with tumours lying \< 1cm from sensitive structures/organs

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