MR-HIFU for Recurrent Gynaecological Cancer

Institute of Cancer Research, United Kingdom31 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cervical Cancer Endometrial Cancer Uterine Cancer Ovarian Cancer Vaginal Cancer

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in pain, measured using a patient diary

Time frame: 7 days post-treatment, follow up at 90 days

Secondary Outcomes

Changes in bleeding, measured using a questionnaire