MR-HIFU for Recurrent Gynaecological Cancer (HIFU-Gynae)

July 13, 2020 updated by: Nandita deSouza, Institute of Cancer Research, United Kingdom

Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU): A Feasibility Study for Treating Recurrent Gynaecological Malignancies

The primary objective of this pilot study is to determine whether or not it is feasible to use MRgHIFU to treat symptomatic (pain, bleeding) recurrent pelvic malignancy with an acceptable safety profile when conventional treatment options are not available. The ultimate goal is to be able not only to offer a viable method of symptom palliation in patients with recurrent pelvic tumours and improve their quality of life; but also to control tumour growth and extend life in a group of relatively young patients with isolated local recurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • The Royal Marsden NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with recurrent pelvic gynaecological malignancy (cervix and endometrial cancer).
  • Recurrent lesion is painful (NRS>4) and not suitable for alternative treatments
  • Intended target volume accessible for MRgHIFU treatment
  • Intended target volume visible on noncontrast MR imaging
  • Distance between target and skin ≥1cm

Exclusion Criteria:

  • MRI contraindicated (e.g. by incompatible metal implants or claustrophobia)
  • Pregnancy
  • Sedation contraindicated
  • MRI contrast agent contraindicated
  • Scar, internal or external fixation device along the beam path or at the target

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Feasibility of MR-HIFU for painful gynaecological metastases
Investigating whether it would be possible to use the MRgHIFU system to treat recurrent gynaecological cancers.
EXPERIMENTAL: Treatment using MR-HIFU of painful gynaecological metastases
Testing whether MRgHIFU could be an effective treatment for the symptoms of recurrent gynaecological cancers (pain and bleeding)
Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in pain, measured using a patient diary
Time Frame: 7 days post-treatment, follow up at 90 days
7 days post-treatment, follow up at 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in bleeding, measured using a questionnaire
Time Frame: 7 days post-treatment, follow up at 90 days
7 days post-treatment, follow up at 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institute of Cancer Research, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ACTUAL)

March 31, 2020

Study Completion (ACTUAL)

March 31, 2020

Study Registration Dates

First Submitted

March 9, 2016

First Submitted That Met QC Criteria

March 16, 2016

First Posted (ESTIMATE)

March 21, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 13, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/WM/0470 CCR4360

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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