Neoplasms

All Conditions

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

microvascular flow imaging

Judith Huirne, Prof.

The investigators hypothesized that Macrovascular Flow imaging could contribute to 2D power Doppler and 3D power Doppler in depicting fibroid vascularity. However, data concerning the feasibility and reproducibility of Macrovascular Flow imaging is lacking. Therefore the purpose of our study was to determine 1) the reproducibility of Macrovascular Flow imaging, 2) its correlation with 2D and 3D power Doppler, and 3) penetration depth, in order to investigate the added value for daily clinical practice.

The Reproducibility of Microvascular Flow Imaging in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes

The Reproducibility of Microvascular Flow in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes: a Prospective Cohort Study

The primary outcome was calculated by the assessment of intercorrelation coefficient (ICC) and its 95% confidence interval (CI) using a two-way mixed model. An ICC value of 0.75-1.00 indicates a good to excellent agreement(19). Bland-Altman plots showed the distribution of data.

The penetration was measured along the direction of the ultrasound wave, from the probe to the deepest ultrasound signal visible, both for Microvascular Flow and power Doppler. Differences in ordinal data was tested by Mann Whitney U, non-normal continuous data by Wilcoxon rank test and normally distributed continuous data by a one sample t-test.

architecture of vessels visible in different regions yes/no.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Investigator Reseach Office Womens Child Center

Symptoms and General Pathology

Neovascularization, Pathologic

All Drugs and Chemicals

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

Hormones

Chrysarobin

Progesterone

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy .

Primary outcome: Natural behaviour - 1 year

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy .

Primary outcome: Long-term exogenous hormonal exposure - 1 year

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy .

Primary outcome: SPRMs or GnRH-analogues - 3 months

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy .

Primary outcome: Initiation of exogenous hormonal exposure - 1 year

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy .

Primary outcome: Embolization - 6 months

To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRMs or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy .

Primary outcome: Ablation therapy - 6 months

Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes. The treatment considering the fibroid(s) is independent of this research. the Also the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test. These measurements are applied in daily practice, as standard care.

Questionnaire

Marjolein Spiering

Rationale: 20-30% of women of reproductive age have leiomyomas, causing symptoms like dysmenorrhea and pelvic pain which both effect quality of life.\[1-4\] The natural behaviour of uterine fibroids is to grow between 7 to 84% in 3 to 12 months.\[5-7\] Non-surgical options to treat uterine fibroids are non-hormonal or hormonal medical therapies and minimally invasive interventional radiologic techniques. Exogenous hormone exposure including COC, POP or Mirena give in conflicting literature minimal growth to 60% volume shrinkage. \[8, 9\]\] Selective progesterone receptor modulators (SPRM) eg. Esmya and GnRH-analogues intent to reduce fibroids volume after several months; GnRH-agonists provide a 31-63% shrinkage and less frequently applied GnRH-antagonists 14.3 - 42.7%.\[10-16\] Esmya gives a volume reduction varying between 10 to 48%.\[17\] Radiological technique like embolization decreases dominant fibroid volume with 40-70%.\[1, 18-22\] UAE fails in case of devascularized or minimal vascularized fibroids.\[23\] Ablation techniques show shrinkage up to a maximum of 90% depending e.g. which treatment.\[24-41\] Clear prognostic models to predict the effect on fibroid related symptoms and volume reduction are lacking. We postulate higher vascularity to be related to 1) larger fibroid growth during the natural course or during exogenous hormonal exposure; 2) more effective shrinkage during progestogens, GnRH-analogues, SPRM and UAE; but 3) less effective after ablation therapy.

Objectives: To study the value of sonographic features including vascularity in the prediction of fibroids' volume change at follow-up during their (1) natural course or (2) long-term use of exogenous hormone exposure; after initiation of (3) SPRM or GnRH-analogues treatment or (4) exogenous hormonal exposure; or after (5) embolization or (6) ablation therapy.

Study design: Observational cohort study during 5 years in the outpatient clinic.

Patientselection: Women ≥18 years with 1 to 3 fibroids with a maximal diameter ≥ 3cm and ≤ 10cm diagnosed on ultrasound examination, planned for expectant or non-surgical management. Study objectives: The primary outcome is volume reduction after 3 to 12 month depending on the study group. The secondary outcome include UFS-QOL, EQ-5D score, PBAC, hemoglobin level, treatment failure rate and (re)intervention rate.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: No risks are associated with the participation of this observational study since the outcome measures include vaginal ultrasound, questionaires and a hemoglobin test. These measurements are also applied in daily practice, the burden for the patient is time. Extra in the context of the study are questionnaires which last a maximum of 5-15 minutes. The treatment considering the fibroid(s) is independent of this research.

Sonographic Features of Fibroids Before and During Non-surgical Therapy and/or Expectant Management

Three directions on 2D ultrasound in centimeters.

UFS-Qol. Total health-related quality of life (29 items, 29-145 points). Or seven subscales: 'symptom severity' (8 items, 8-40 points), 'concern' (5 items, 5-25 points), 'activities' (7 items, 7-35 points), 'energy/mood' (7 items, 7-35 points), 'control' (5 items, 5-25 points), 'self-conscious' (3 items, 3-15 points), 'sexual function' (2 items, 2-10 points). The higher, the lower the quality of life.

EQ-5D. Range 0 - 1. The higher, the lower the quality of life.

PBAC. Range 0 to no maximum. PBAC \> 150 is heavy menstrual bleeding. The higher, the more bloodloss.

Percentage of patients who underwent re-intervention (e.g. embolization, operation, etc) for their fibroid(s) in follow-up period. Range: 0-100%, the higher, the more re-interventions.

Percentage of patients who started additional treatment (e.g. medication, etc) for their fibroid(s) in follow-up period. Range: 0-100%, the higher, the more treatment failures.

According to local protocol, standard care, mmol/L (range 0-20). A lower haemoglobin level corresponds with more menstrual bloodloss and/or anemia.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
The Reproducibility of Microvascular Flow Imaging in Fibroids and Its Correlation With 2D and 3D Power Doppler Outcomes	NCT05643339	Fibroid Uterus	microvascular f...	18 Years - 50 Years	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sonographic Features of Fibroids Before and During Non-surgical Therapy and/or Expectant Management	NCT05741671	Fibroid Uterus	Questionnaire	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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