Cervical Cancer, Endometrial Cancer, Ovarian Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer
Conditions
Keywords
Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU), Focused Ultrasound Surgery
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.
Interventions
Sponsors
Institute of Cancer Research, United Kingdom
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in pain, measured using a patient diary | 7 days post-treatment, follow up at 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Changes in bleeding, measured using a questionnaire | 7 days post-treatment, follow up at 90 days |
Countries
United Kingdom
Outcome results
None listed