MR-HIFU for Recurrent Gynaecological Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Cervical Cancer, Endometrial Cancer, Uterine Cancer, Ovarian Cancer, Vaginal Cancer, Vulvar Cancer

Intervention / Treatment
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* Device: Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Feasibility of MR-HIFU for painful gynaecological metastases<br>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<br>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)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in pain, measured using a patient diary |  | 7 days post-treatment, follow up at 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in bleeding, measured using a questionnaire |  | 7 days post-treatment, follow up at 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU), Focused Ultrasound Surgery