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Completed

NCT Number: NCT02714621

MR-HIFU for Recurrent Gynaecological Cancer

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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Key information

Conditions

Cervical Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cancer Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulvar Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)

Device

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

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Registry information

Official study title

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

Acronym: HIFU-Gynae

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Mar 21, 2016
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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