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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02714621
Recruitment Status : Completed
First Posted : March 21, 2016
Last Update Posted : July 15, 2020
Sponsor:
Information provided by (Responsible Party):
Nandita deSouza, Institute of Cancer Research, United Kingdom

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Endometrial Cancer Uterine Cancer Ovarian Cancer Vaginal Cancer Vulvar Cancer Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU): A Feasibility Study for Treating Recurrent Gynaecological Malignancies
Study Start Date : May 2016
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020


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)



Primary Outcome Measures :
  1. Changes in pain, measured using a patient diary [ Time Frame: 7 days post-treatment, follow up at 90 days ]

Secondary Outcome Measures :
  1. Changes in bleeding, measured using a questionnaire [ Time Frame: 7 days post-treatment, follow up at 90 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02714621


Locations
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United Kingdom
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom, SM2 5PT
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom
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Responsible Party: Nandita deSouza, Professor of Translational Imaging, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02714621    
Other Study ID Numbers: 15/WM/0470 CCR4360
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Keywords provided by Nandita deSouza, Institute of Cancer Research, United Kingdom:
Magnetic Resonance Imaging (MRI)
High Intensity Focused Ultrasound (HIFU)
Focused Ultrasound Surgery
Additional relevant MeSH terms:
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Endometrial Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Vulvar Diseases
Vaginal Diseases