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Clinical Trials/NCT02714621
NCT02714621
Completed
Not Applicable

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

Institute of Cancer Research, United Kingdom1 site in 1 country31 target enrollmentMay 2016
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ConditionsCervical CancerEndometrial CancerUterine CancerOvarian CancerVaginal CancerVulvar Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cervical Cancer
Sponsor
Institute of Cancer Research, United Kingdom
Enrollment
31
Locations
1
Primary Endpoint
Changes in pain, measured using a patient diary
Status
Completed
Last Updated
5 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2016
End Date
March 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
Institute of Cancer Research, United Kingdom
Responsible Party
Principal Investigator
Principal Investigator

Nandita deSouza

Professor of Translational Imaging

Institute of Cancer Research, United Kingdom

Eligibility Criteria

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(7 days post-treatment, follow up at 90 days)

Study Sites (1)

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