HIFU-Gynae: MR-HIFU for Recurrent Gynaecological Cancer

Sponsor

Institute of Cancer Research, United Kingdom (Other)

Overall Status

Completed

CT.gov ID

NCT02714621

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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)	N/A

Study Design

Study Type:

Interventional

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 1, 2016

Actual Primary Completion Date :

Mar 31, 2020

Actual Study Completion Date :

Mar 31, 2020

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Changes in pain, measured using a patient diary [7 days post-treatment, follow up at 90 days]

Secondary Outcome Measures

Changes in bleeding, measured using a questionnaire [7 days post-treatment, follow up at 90 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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