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Exploring HIFU as a Treatment for Rectal and Other Pelvic Cancers

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ClinicalTrials.gov Identifier: NCT03595722
Recruitment Status : Recruiting
First Posted : July 23, 2018
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
SonaCare Medical
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Rectal Neoplasms Pelvic Cancer Endometrial Cancer Cervical Cancer Device: High Intensity Focused Ultrasound Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Intensity Focused Ultrasound as a Treatment for Rectal and Pelvic Cancers - Laboratory and Clinical Feasibility Studies
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : August 28, 2022
Estimated Study Completion Date : August 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Early rectal cancer
Patients with early rectal cancer undergoing a treat and resect pathway - patients will be treated with high intensity focused ultrasound 7-10 days prior to the surgical resection of their rectal cancer
Device: High Intensity Focused Ultrasound
High intensity focused ultrasound to rectal/pelvic cancer

Experimental: Late pelvic cancer
Patients with late pelvic (rectal, endometrial, cervical) cancer will undergo a treat and observe pathway - patients will be treated with high intensity focused ultrasound and their response will be observed
Device: High Intensity Focused Ultrasound
High intensity focused ultrasound to rectal/pelvic cancer




Primary Outcome Measures :
  1. Complications [ Time Frame: 0-30 days ]
    Complications and toxicity of HIFU treatment


Secondary Outcome Measures :
  1. Symptom control [ Time Frame: 7-90 days ]
    Quality of life questionnaire responses

  2. Histological tissue changes [ Time Frame: 7-10 days ]
    Histological changes in tumour and surrounding tissue

  3. Tumour marker changes [ Time Frame: 7-90 days ]
    Changes in circulating tumour markers

  4. Inflammatory marker changes [ Time Frame: 7-90 days ]
    changes in circulating inflammatory markers

  5. Radiological changes [ Time Frame: 30 days ]
    MRI changes in tumour



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT03595722


Contacts
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Contact: Ovuefe Efeotor +447729459614 oe408@imperial.ac.uk

Locations
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United Kingdom
Imperial College London Recruiting
London, United Kingdom, W2 1NY
Contact: Ovuefe Efeotor    +447729459614    oe408@imperial.ac.uk   
Principal Investigator: Jamie Murphy, Phd         
Sponsors and Collaborators
Imperial College London
SonaCare Medical
Investigators
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Principal Investigator: Jamie Murphy, PhD Imperial College London

Publications:
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03595722     History of Changes
Other Study ID Numbers: 18SM4430
First Posted: July 23, 2018    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Imperial College London:
Pelvic cancer
rectal cancer
HIFU
QoL
complications

Additional relevant MeSH terms:
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Rectal Neoplasms
Uterine Cervical Neoplasms
Endometrial Neoplasms
Pelvic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female