NCT02714621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

July 15, 2020

Status Verified

July 1, 2020

Enrollment Period

3.9 years

First QC Date

March 9, 2016

Last Update Submit

July 13, 2020

Conditions

Cervical CancerEndometrial CancerUterine CancerOvarian CancerVaginal CancerVulvar Cancer

Keywords

Magnetic Resonance Imaging (MRI)High Intensity Focused Ultrasound (HIFU)Focused Ultrasound Surgery

Outcome Measures

Primary Outcomes (1)

  • Changes in pain, measured using a patient diary

    7 days post-treatment, follow up at 90 days

Secondary Outcomes (1)

  • Changes in bleeding, measured using a questionnaire

    7 days post-treatment, follow up at 90 days

Study Arms (2)

Feasibility of MR-HIFU for painful gynaecological metastases

NO INTERVENTION

Investigating whether it would be possible to use the MRgHIFU system to treat recurrent gynaecological cancers.

Treatment using MR-HIFU of painful gynaecological metastases

EXPERIMENTAL

Testing whether MRgHIFU could be an effective treatment for the symptoms of recurrent gynaecological cancers (pain and bleeding)

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

Interventions

Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)DEVICE
Treatment using MR-HIFU of painful gynaecological metastases

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 33882792DERIVED

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsUterine NeoplasmsOvarian NeoplasmsVaginal NeoplasmsVulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersVaginal DiseasesVulvar Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Translational Imaging

Study Record Dates

First Submitted

March 9, 2016

First Posted

March 21, 2016

Study Start

May 1, 2016

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

July 15, 2020

Record last verified: 2020-07

Locations

GB(1)