MR-HIFU for Recurrent Gynaecological Cancer

Ovarian Cancer Clinical Trial

— HIFU-Gynae  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02714621
• Other study ID #: 15/WM/0470 CCR4360
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2020
• Source: Institute of Cancer Research, United Kingdom
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer
• Uterine Cancer
• Uterine Neoplasms
• Vaginal Cancer
• Vaginal Neoplasms
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Cancer Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in pain, measured using a patient diary		7 days post-treatment, follow up at 90 days
Secondary	Changes in bleeding, measured using a questionnaire		7 days post-treatment, follow up at 90 days