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

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ClinicalTrials.gov Identifier: NCT02714621
Recruitment Status : Recruiting
First Posted : March 21, 2016
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
NdeSouza, 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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 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
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


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 ]


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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


Contacts
Contact: Sharon Giles, MSc 0208 915 6493 sharon.giles@rmh.nhs.uk
Contact: Nandita deSouza, Professor 0208 661 3289 nandita.desouza@icr.ac.uk

Locations
United Kingdom
The Royal Marsden NHS Foundation Trust Recruiting
Surrey, United Kingdom, SM2 5PT
Contact: Sharon Giles    02089156493    Sharon.Giles@rmh.nhs.uk   
Sponsors and Collaborators
Institute of Cancer Research, United Kingdom

Responsible Party: NdeSouza, Professor of Translational Imaging, Institute of Cancer Research, United Kingdom
ClinicalTrials.gov Identifier: NCT02714621     History of Changes
Other Study ID Numbers: 15/WM/0470 CCR4360
First Posted: March 21, 2016    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017

Keywords provided by NdeSouza, Institute of Cancer Research, United Kingdom:
Magnetic Resonance Imaging (MRI)
High Intensity Focused Ultrasound (HIFU)
Focused Ultrasound Surgery

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Endometrial Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Vulvar Diseases
Vaginal Diseases