MR-HIFU for Recurrent Gynaecological Cancer

Not Applicable

Completed

• Conditions: Endometrial Cancer; Ovarian Cancer; Vaginal Cancer; Vulvar Cancer; Cervical Cancer; Uterine Cancer
• Interventions: Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)

• Registration Number: NCT02714621
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-16
• Study First Posted: 2016-03-21
• Study Start: 2016-05
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-13
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment using MR-HIFU of painful gynaecological metastases	Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)	Testing whether MRgHIFU could be an effective treatment for the symptoms of recurrent gynaecological cancers (pain and bleeding)

Primary Outcome Measures

Name	Time	Method
Changes in pain, measured using a patient diary	7 days post-treatment, follow up at 90 days

Secondary Outcome Measures

Name	Time	Method
Changes in bleeding, measured using a questionnaire	7 days post-treatment, follow up at 90 days

Trial Locations

Locations (1)

The Royal Marsden NHS Foundation Trust; 🇬🇧 Sutton, Surrey, United Kingdom