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

Institute of Cancer Research, United Kingdom

Status: Completed

Conditions: Endometrial Cancer; Uterine Cancer; Vulvar Cancer; Vaginal Cancer; Ovarian Cancer; Cervical Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT02714621

15/WM/0470 CCR4360

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 2 patient groups

Feasibility of MR-HIFU for painful gynaecological metastases

No Intervention group

Description:

Investigating whether it would be possible to use the MRgHIFU system to treat recurrent gynaecological cancers.

Treatment using MR-HIFU of painful gynaecological metastases

Experimental group

Description:

Testing whether MRgHIFU could be an effective treatment for the symptoms of recurrent gynaecological cancers (pain and bleeding)

Treatment:

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