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CompletedNCT02714621HIFU-GynaeUpdated Jul 15, 2020

MR-HIFU for Recurrent Gynaecological Cancer

An interventional study of Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) in Cervical Cancer, Endometrial Cancer and Uterine Cancer, sponsored by Institute of Cancer Research, United Kingdom. Completed at 1 site in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-15.

Sponsored by Institute of Cancer Research, United Kingdom · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Cervical Cancer
  • Endometrial Cancer
  • Uterine Cancer
  • Ovarian Cancer
  • Vaginal Cancer
  • Vulvar Cancer

Keywords

  • Magnetic Resonance Imaging (MRI)
  • High Intensity Focused Ultrasound (HIFU)
  • Focused Ultrasound Surgery
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In context

Endometrial Neoplasms

1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.

This study's enrollment of 31 is below the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Institute of Cancer Research, United Kingdom is the lead sponsor of 111 studies on the registry; 27 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
31 participants (actual)

Study arms

  • 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)

Interventions

  • DeviceMagnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
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What researchers measure

Primary outcomes

  1. Changes in pain, measured using a patient diary

    Time frame: 7 days post-treatment, follow up at 90 days

Secondary outcomes

  1. Changes in bleeding, measured using a questionnaire

    Time frame: 7 days post-treatment, follow up at 90 days

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Study locations

1 site
  • The Royal Marsden NHS Foundation Trust
    Sutton, Surrey SM2 5PT, United Kingdom
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References and documents

Publications

  • Imseeh G, Giles SL, Taylor A, Brown MRD, Rivens I, Gordon-Williams R, Ter Haar G, deSouza NM. Feasibility of palliating recurrent gynecological tumors with MRGHIFU: comparison of symptom, quality-of-life, and imaging response in intra and extra-pelvic disease. Int J Hyperthermia. 2021;38(1):623-632. doi: 10.1080/02656736.2021.1904154. PubMed 33882792 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 15, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02714621
Lead sponsor
Institute of Cancer Research, United Kingdom
Responsible party
Nandita deSouza (Professor of Translational Imaging, Institute of Cancer Research, United Kingdom) — Principal investigator
First posted
Mar 21, 2016
Start date
May 2016
Primary completion
Mar 31, 2020
Completion
Mar 31, 2020
Last update
Jul 15, 2020
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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