Back to resultsMR-HIFU for Recurrent Gynaecological Cancer (HIFU-Gynae)
Primary Purpose
Cervical Cancer, Endometrial Cancer, Uterine Cancer
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Cancer focused on measuring Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU), Focused Ultrasound Surgery
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
Sites / Locations
- The Royal Marsden NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Feasibility of MR-HIFU for painful gynaecological metastases
Treatment using MR-HIFU of painful gynaecological metastases
Arm Description
Investigating whether it would be possible to use the MRgHIFU system to treat recurrent gynaecological cancers.
Testing whether MRgHIFU could be an effective treatment for the symptoms of recurrent gynaecological cancers (pain and bleeding)
Outcomes
Primary Outcome Measures
Changes in pain, measured using a patient diary
Secondary Outcome Measures
Changes in bleeding, measured using a questionnaire
Full Information
NCT ID
NCT02714621
First Posted
March 9, 2016
Last Updated
July 13, 2020
Sponsor
Institute of Cancer Research, United Kingdom
1. Study Identification
Unique Protocol Identification Number
NCT02714621
Brief Title
MR-HIFU for Recurrent Gynaecological Cancer
Acronym
HIFU-Gynae
Official Title
Magnetic Resonance Guided High Intensity Focused Ultrasound (MRgHIFU): A Feasibility Study for Treating Recurrent Gynaecological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 31, 2020 (Actual)
Study Completion Date
March 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Cancer Research, United Kingdom
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Endometrial Cancer, Uterine Cancer, Ovarian Cancer, Vaginal Cancer, Vulvar Cancer
Keywords
Magnetic Resonance Imaging (MRI), High Intensity Focused Ultrasound (HIFU), Focused Ultrasound Surgery
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feasibility of MR-HIFU for painful gynaecological metastases
Arm Type
No Intervention
Arm Description
Investigating whether it would be possible to use the MRgHIFU system to treat recurrent gynaecological cancers.
Arm Title
Treatment using MR-HIFU of painful gynaecological metastases
Arm Type
Experimental
Arm Description
Testing whether MRgHIFU could be an effective treatment for the symptoms of recurrent gynaecological cancers (pain and bleeding)
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)
Primary Outcome Measure Information:
Title
Changes in pain, measured using a patient diary
Time Frame
7 days post-treatment, follow up at 90 days
Secondary Outcome Measure Information:
Title
Changes in bleeding, measured using a questionnaire
Time Frame
7 days post-treatment, follow up at 90 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
The Royal Marsden NHS Foundation Trust
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
33882792
Citation
Imseeh G, Giles SL, Taylor A, Brown MRD, Rivens I, Gordon-Williams R, Ter Haar G, deSouza NM. Feasibility of palliating recurrent gynecological tumors with MRGHIFU: comparison of symptom, quality-of-life, and imaging response in intra and extra-pelvic disease. Int J Hyperthermia. 2021;38(1):623-632. doi: 10.1080/02656736.2021.1904154.
Results Reference
derived
Learn more about this trial
MR-HIFU for Recurrent Gynaecological Cancer
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