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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU) | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in pain, measured using a patient diary | 7 days post-treatment, follow up at 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in bleeding, measured using a questionnaire | 7 days post-treatment, follow up at 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Royal Marsden NHS Foundation Trust | Sutton | Surrey | SM2 5PT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33882792 | Derived | 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. |
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| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D014594 | Uterine Neoplasms |
| D010051 | Ovarian Neoplasms |
| D014625 | Vaginal Neoplasms |
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D002577 |
| Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014623 | Vaginal Diseases |
| D014845 | Vulvar Diseases |