Neoplasms

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Thyroid Neoplasms

Thyroid Diseases

Hypoparathyroidism

Neovascularization, Pathologic

Endocrine System Diseases

Parathyroid Diseases

Metaplasia

All Drugs and Chemicals

Parathyroid Hormone

Patients who undergo thyroid surgery and receive indocyanine green angiography

Indocyanine green is used to perform intraoperative angiography.

Indocyanine green

The device is used to perform intraoperative angiography.

SPY Portable Handheld Imaging (SPY-PHI)

Riccardo Rosati, Prof.

Prospective, observational, single-center study about the use of indocyanine green angiography during total thyroidectomy.

The main objective of the study is to identify a quantitative score of parathyroid vascularization as an outcome of angiography that correlates with the absence of postoperative hypoparathyroidism.

It is planned to enroll 66 patients.

Postoperative hypoparathyroidism and subsequent hypocalcemia are the most frequent complications after thyroid surgery. The incidence ranges from 19-38%, depending on the definition of hypoparathyroidism and hypocalcemia.

Although the cause of postoperative hypoparathyroidism is multifactorial, one of the most important factors is vascularization of parathyroid glands left in situ that is insufficient or impaired by surgical manipulation. Therefore, one of the goals of thyroid surgery is not only to recognize the parathyroid glands during dissection but also to respect their vascularization in order to preserve well perfused and viable glands.

The general objective of this study is to quantitatively assess the vascularization of the parathyroids following total thyroid removal.

In particular, the investigators intend to obtain data regarding parathyroid vascularization during total thyroidectomy with indocyanine green angiography. During standard surgery, angiography will be performed using a special camera after having administered intravenously indocyanine green. This technique is used to objectively assess the degree of fluorescence of the parathyroid glands.

Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography

Analysis of Parathyroid Vascularization During Total Thyroidectomy Using Quantitative Real-time Indocyanine Green Angiography

A quantitative score of parathyroid vascularization as an outcome of indocyanine green angiography during thyroidectomy that correlates with the absence of postoperative hypoparathyroidism.

The score will be reported as a percentage (range 0% - 200%) where the higher score means the better outcome.

IRCCS San Raffaele

Principal Investigator

Skin and Connective Tissue Diseases

Leiomyoma

Myofibroma

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

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

Judith Huirne, Prof.

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.

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

Investigator Reseach Office Womens Child Center

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Ovarian Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Gonadal Disorders

Ovarian Cancer

Contrast enhanced ultrasound using Sonovue / 2.4 ml per injection - one or two injections (maximum of 9.6 ml).

Contrast-enhanced ultrasound

Henri Marret, PR

François Tranquart, PR

This study intends to assess the ability of contrast-enhanced ultrasound in the detection of benign and malignant ovarian masses compared to unenhanced ultrasound.

By using an intravascular contrast agent, this noninvasive and feasible imaging technique will allow the investigators to define specific microcirculation patterns in 100 women with ovarian lesions.

The intravascular contrast agent properties will be compared between benign and malignant adnexal masses.

The final purpose of this ultrasonography is to allow the early detection of tumors and to improve the characterization between benign and malignant lesions.

SonoVue (Sulphur hexafluoride microbubbles) is a microbubbles preparation that is stable, resistant to pressure and specifically designed to be used as a contrast agent for ultrasound imaging.

Study design : one contrast-enhanced ultrasonography is proposed before any surgery to patients with ovarian mass.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Parathyroid Vascularization During Total Thyroidectomy Using Indocyanine Green Angiography	NCT05328076	Thyroid Thyroid Cancer Hypoparathyroid... Vascularization	Indocyanine gre... SPY Portable Ha...	18 Years -	IRCCS San Raffaele
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)
Contrast-Enhanced Ultrasound Ability in the Characterization of Ovarian Masses	NCT00248820	Ovarian Tumor	Contrast-enhanc...	18 Years -	University Hospital, Tours

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