MR-HIFU for Recurrent Gynaecological Cancer

NCT ID: NCT02714621

Last Updated: 2020-07-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-05-31
• Study Completion Date: 2020-03-31

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.

Conditions

Cervical Cancer; Endometrial Cancer; Uterine Cancer; Ovarian Cancer; Vaginal Cancer; Vulvar Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Feasibility of MR-HIFU for painful gynaecological metastases

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment using MR-HIFU of painful gynaecological metastases

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

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

Interventions

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

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role: lead

Responsible Party

Nandita deSouza

Professor of Translational Imaging

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 33882792 (View on PubMed)

Other Identifiers

15/WM/0470 CCR4360

Identifier Type: -

Identifier Source: org_study_id