Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Fibroadenoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

HIFU treatment in patient diagnosed with fibroadenoma

HIFU treatment in patients with fibroadenoma

HIFU treatment

Michael Douek, MD

The purpose of this study is to assess the treatment of fibroadenomata with a circumferential sonification treatment with HIFU..

Primary endpoint: fibroadenomata size reduction post-treatment on ultrasound imaging.

Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU

High Intensity Focused Ultrasound for the Treatment of Fibroadenomata (HIFU-F)

King's College London

Theraclion

Leiomyoma

Myofibroma

Connective Tissue Diseases

Vincent, YT Cheung, MBBS, FRCOG

Uterine fibroids are common uterine benign neoplasm. They can cause abnormal menstrual bleeding, pelvic discomfort and urinary frequency. Although surgical intervention is the definitive treatment, some women prefer to have their uterus preserved. High-intensity focused ultrasound (HIFU) therapy is receiving increasing interest in the management of uterine fibroids by inducing focal thermocoagulation of the fibroids. Results obtained by various research groups have shown that HIFU treatment is safe, effective and is highly acceptable to patients. The main objective of this study is to evaluate the therapeutic efficacy of HIFU in the treatment of uterine fibroids.

In this proposed study, 20 patients who have symptomatic uterine fibroids who meet the study inclusion criteria will be invited to participate in the study which involves the use of HIFU in the management of the fibroid. Background information of the patients such as age, body mass index, hormonal (pre- or postmenopausal) status and the presence of chronic medical disease will be collected. Subjects will also be asked to complete an eight-item section of a Uterine Fibroid Symptom and Quality Of Life Questionnaire (UFS-QOL) which evaluate the effect of the fibroid on the quality of life of women.

High-intensity Focused Ultrasound in Treatment of Uterine Fibroid

Therapeutic Efficacy of High-intensity Focused Ultrasound in the Treatment of Uterine Fibroid

By sonographic measurements at baseline, post 1-month, post 3-month, and post 12-month, the size of the uterine fibroids will be evaluated by physicians

Patients will be asked to give the satisfaction score (0= not satisfactory, 5= very satisfactory) at each follow up (i.e. post treatment 1 months, 3 months, 6 months and 12 months)

By using the Uterine Fibroid Symptoms Quality Of Life Questionnaire (UFS_QOL) at each follow up (i.e. from baseline to post 1- month, post 1-month to post 3-month, post 3-month to post 6-month, post 6-month to post 12-month treatment will be captured).

Patient will be evaluated for abnormal laboratory values and/or adverse events that are related to treatment at each follow up (i.e. post treatment 1 months, 3 months, 6 months and 12 months)

By physician's judgment at each follow up (i.e. at post treatment 1 months, 3 months, 6 months and 12 months), the need for subsequent additional treatments (such as hysterectomy, uterine artery embolization, or any type of hormonal treatment) will be evaluated.

By MRI measurements at baseline, post 6-month, the size of the uterine fibroids will be evaluated by physicians

Queen Mary Hospital, Hong Kong

Gland and Hormone Related Diseases

Thyroid Diseases

Thyroid Nodule

Endocrine System Diseases

Thyroid Neoplasms

Endocrine Gland Neoplasms

Head and Neck Neoplasms

use of HIFU treatment in patients with non-malignant thyroid nodules

Roussanka Kovatcheva, Prof.

The purpose of this study is to evaluate thyroid nodule's volume, structure and vascularisation changes following HIFU therapy assessed by ultrasonography

HIFU treatment will be performed under conscious sedation under the supervision / responsibilities of an anesthetist.

A maximum of 2 HIFU sessions per nodule will be performed per patient. The decision to retreat the patient will be taken at 1 month post-HIFU or later.

Follow-up after HIFU treatment

D1 after HIFU session:

* Indirect laryngoscopy to check vocal cord mobility.

D7 after HIFU session

* Clinical examination (skin, local symptoms, oedema, voice....),
* Ultrasonography and Power Doppler,

M1 after HIFU session

* Clinical examination (skin, local symptoms, oedema, voice....),
* Ultrasonography and Power Doppler,

M3 after HIFU session

* Clinical examination (skin, local symptoms, oedema, voice....),
* Ultrasonography and Power Doppler Decision for an additional HIFU course to improve volume reduction.

In case of a second HIFU session D7b, M1b and M3b, M6b, M9b, M12b, M18b, M24b and M36b will be performed

M6 after last HIFU session

* Clinical examination (skin, local symptoms, oedema, voice....),
* Ultrasonography and Power Doppler
* TSH
* Free T4
* Antithyroid peroxidase antibodies
* Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)

M9 after HIFU session

* Clinical examination (skin, local symptoms, oedema, voice....),
* Ultrasonography and Power Doppler

M12 after last HIFU session

* Clinical examination (skin, local symptoms, oedema, voice....),
* Ultrasonography and Power Doppler
* TSH
* Free T4
* Antithyroid peroxidase antibodies
* Calcemia and PTH (in case of bilateral treatment or in case previous thyroid surgery)

M18, M24, M36 after HIFU session

* Clinical examination (skin, local symptoms, oedema, voice....),
* Ultrasonography and Power Doppler

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU	NCT02139683	Breast Fibroade...	HIFU treatment	18 Years -	Theraclion
High-intensity Focused Ultrasound in Treatment of Uterine Fibroid	NCT02954744	Fibroids	HIFU treatment	30 Years - 60 Years	Queen Mary Hospital, Hong Kong
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.	NCT02246504	Non-malignant T...	HIFU treatment	18 Years -	Theraclion
Feasibility Study Assessing the Treatment of Fibroadenomata With a Circumferential Sonication Treatment With HIFU	NCT02139683	Breast Fibroade...	HIFU treatment	18 Years -	Theraclion
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.	NCT02246504	Non-malignant T...	HIFU treatment	18 Years -	Theraclion
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.	NCT02246504	Non-malignant T...	HIFU treatment	18 Years -	Theraclion
Registry - Use of a High Intensity Focused Ultrasound (HIFU) in Patients With Non-malignant Thyroid Nodules.	NCT02246504	Non-malignant T...	HIFU treatment	18 Years -	Theraclion
High-intensity Focused Ultrasound in Treatment of Uterine Fibroid	NCT02954744	Fibroids	HIFU treatment	30 Years - 60 Years	Queen Mary Hospital, Hong Kong

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