Subjects undergoing CT-guided, minimally invasive percutaneous procedures in an interventional radiology setting

The system is used for trajectory planning and is intended to assist the physician in the positioning of an instrument, such as a needle, where CT imaging is used for target trajectory planning and intraoperative tracking. The XACT ACE Robotic System uses a computerized quantitative guidance system, which provides real-time, accurate needle guidance, including advancement and steering of the needle from the entry point on the subject's body to the target point within the body.

Hands-free, user-controlled robotic system intended to assist in the planning and advancement of an instrument during CT guided percutaneous procedures. T

Mark Macedo

Nanette Matrullo

Sebastian Flacke, MD

Compile real world data on the use of the XACT ACE Robotic System

The purpose of this observational post-market study is to compile real world data on the use of the XACT ACE Robotic System in subjects undergoing CT guided, minimally invasive percutaneous procedures.

The objectives are to 1) evaluate the proportion of procedures in which the instrument reached the pre-defined target, based on the physician's determination and CT imaging confirmation, 2) To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the at the end of the instrument insertion, and 3) Incidence of intra- and post-procedural adverse events.

Up to 500 patients will be enrolled in this multicenter, nonrandomized, single arm registry.

XACT ACE Observational Registry

Observational Post-Market Study of the XACT ACE Robotic System

To evaluate the proportion of procedures in which the instrument reached the pre-defined target based on the physician's determination and CT imaging confirmation.

To evaluate system accuracy defined as the measured distance from the tip of the instrument to the target location at the end of the instrument insertion.

Incidence of intra- and post-procedural events

Xact Robotics Ltd.

Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Diseases and Abnormalities at or Before Birth

Syndrome

Polycystic Ovary Syndrome

Hyperandrogenism

Amenorrhea

Gonadal Disorders

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Endocrine System Diseases

Menstruation Disturbances

Hypoglycemic Agents

All Drugs and Chemicals

Vasoconstrictor Agents

Respiratory System Agents

Insulin

Insulin, Globin Zinc

Hormones

Epinephrine

Racepinephrine

Epinephryl borate

10 women with exercise-associated hypothalamic amenorrhea

5 lean women with hyperandrogenic polycystic ovary syndrome. 5 women with weight excess and hyperandrogenic polycystic ovary syndrome.

5 lean women with non-hyperandrogenic polycystic ovary syndrome 5 women with weight excess and non-hyperandrogenic polycystic ovary syndrome

10 women who exercise as intensively as women with exercise-associated hypothalamic amenorrhea but with normal ovulatory cycles.

10 women matched by age and body mass index with women with polycystic ovary syndrome who do not perform physical activity on a regular basis

* Weight and height.
* Waist-to-hip ratio.
* Body composition: Bioelectrical impedance and \[Dual energy X-ray absorptiometry (DEXA)\].

Anthropometric and physical examination

Indirect calorimetry, accelerometer and seven-day dietary recall

* Lipid profile.
* Oral glucose tolerance test: plasma glucose and insulin, insulin sensitivity indices, gastrointestinal hormones, adipokines, oxidative stress markers.
* Sex steroid profile.
* Hypothalamic-pituitary-adrenal axis study.
* Ferrokinetic study.
* Subclinical chronic inflammatory markers.

Biochemical, hormonal and metabolic phenotyping

* Polycystic ovarian morphology.
* Carotid intima-media thickness.
* Eco-FAT: Ultrasound measurements of adipose tissue depots including sc, preperitoneal, intraperitoneal (ip), mesenteric, and perirenal fat thickness.

Sonographic studies

A\&D TM2430EX oscillometric devices (A\&D Company Limited, Tokyo, Japan).

24-hour Ambulatory blood pressure monitoring

Subcutaneous fat tissue and muscle tissue for proteomics an gene expression studies.

Percutaneous biopsy

Parasympathetic and sympathetic responses to deep breathing, Valsalva's maneuver and orthostatism.

Cardiovascular autonomic function studies

Oral smear and feces specimen

Elena Fernández Durán

Héctor F Escobar-Morreale, PhD, MD

Manuel Luque-Ramírez, PhD, MD

Reproduction requires from women enough energy depots to warrant an adequate nutritional supply to the fetus. Hence, adipose tissue is able to communicate with female hypothalamic-pituitary-ovary axis. The hypothesis of the project is that abnormalities in the quantity (absolute and relative to lean body mass), distribution and/or function of adipose tissue are associated with functional forms of female gonadal dysfunction in predisposed women, in a spectrum of anomalies that go from hypothalamic amenorrhea to the polycystic ovary syndrome (PCOS). To challenge this hypothesis, the investigators will study 5 groups of 10 women each: women with exercise-associated hypothalamic amenorrhea, women without ovulatory dysfunction that exercise equally, non-hyperandrogenic patients with PCOS, hyperandrogenic patients with PCOS, and healthy control women comparable to those with PCOS. The aims of the study will be:

Primary objective: To identify novel signalling factors originating from adipose tissue and muscle using targeted and nontargeted evaluation of the proteome and of gene expression of superficial subcutaneous fat, deep subcutaneous fat (which mimics visceral adipose tissue) and skeletal muscle.

Secondary objectives:

1. To study the serum adipokine profile - including those identified by the primary objective - and circulating gut hormones during fasting and after a glucose load in the 5 groups of women, and their associations with sexual hormones and body fat distribution.
2. To study body composition and body fat distribution in these women and their relationships with:

2.1, Sex steroid profiles.

2.2. Classic cardiovascular risk factors: carbohydrate metabolism, lipid profiles and blood pressure.

2.3 Markers of low-grade chronic inflammation.

2.4. Oxidative stress markers.

2.5. Cardiovascular autonomic function.

2.6. Surrogate markers of subclinical atherosclerosis.

2.7. Circulating concentrations of endocrine disruptors.

2.8. Oral and gut microbiome.

The results will provide a better understanding of the mechanisms linking body energy depots with the female reproductive axis and, hopefully, the identification of potential biomarkers for the diagnosis and treatment of the disorders studied here.

Serum Plasma Whole blood samples Subcutaneous adipose tissue by percutaneous biopsy Muscle tissue by percutaneous biopsy Feces Oral smear

Body Fat as Determinant of Female Gonadal Dysfunction

Amount, Distribution and Dysfunction of Body Fat as Determinants of Female Gonadal Dysfunction: From Functional Hypothalamic Amenorrhea to the Polycystic Ovary Syndrome

The investigators will deposit any datasets and supplemental materials to a generalist repository. The investigators will refer to the deposited material as an item in the bibliography of any manuscript and number the reference appropriately within the text.

At fasting and after an oral glucose challenge: Circulating concentrations of Leptin, Adiponectin, Chemerin, Lipocalin-2, Adipsin, Plasminogen Activator Inhibitor (PAI)-1, Monocyte Chemoattractant Protein (MCP)-1, and Soluble Leptin Receptor by multianalyte profiling on the Luminex Magpix system (Luminex Technologies, Austin, USA.).

At fasting and after an oral glucose challenge: Circulating concentrations of Amylin, C-Peptide, Ghrelin, Gastric Inhibitory Peptide (GIP), Glucagon-Like Peptide (GLP)-1, Glucagon, IL-6, Insulin, Pancreatic Polypeptide (PP), Peptide YY, Tumor Necrosis Factor (TNF)-α by multianalyte profiling on the Luminex Magpix system (Luminex Technologies, Austin, USA.).

Body mass index in in kg/m\^2. Sex steroids (including circulating total testosterone, estradiol, androstenedione, dehydroepiandrosterone-sulphate and estrone) measured by liquid chromatography tandem mass spectrometry (LC-MS/MS). Free testosterone will be calculated from total testosterone and sex hormone binding globulin levels.

Fat mass% by bioelectric impedanciometry and DEXA. Sex steroids (including circulating total testosterone, estradiol, androstenedione, dehydroepiandrosterone-sulphate and estrone) measured by liquid chromatography tandem mass spectrometry (LC-MS/MS). Free testosterone will be calculated from total testosterone and sex hormone binding globulin levels.

Lean mass% by bioelectric impedanciometry and DEXA. Sex steroids (including circulating total testosterone, estradiol, androstenedione, dehydroepiandrosterone-sulphate and estrone) measured by liquid chromatography tandem mass spectrometry (LC-MS/MS). Free testosterone will be calculated from total testosterone and sex hormone binding globulin levels.

Adipose tissue depots will be estimated using a Toshiba Nemio XG SSA-580A Diagnostic Ultrasound System. Minimum sc and preperitoneal fat thicknesses will be measured at the level of the xyphoid process. Maximum sc fat thickness will be measured at the level of the umbilicus. Intraperitoneal fat thickness will be measured placing a probe transversally in the midline of abdomen, 2 cm above the umbilicus. Three measures of ip fat thickness will be obtained: the distance from the fascia of rectus abdominis muscle to the vertebral column, the distance from the peritoneum to the vertebral column, and the distance from the linea alba to the vertebral column. Perirenal fat thickness will be estimated as the distance from the perirenal fascia to the renal surface. Sex steroids will be measured as previously described.

Fat mass, lean mass and body fat depots will be measured as previously described. Fasting glucose and insulin levels will be used for calculating the homeostasis model assessment of insulin resistance (HOMA-IR), and the composite insulin sensitivity index will be estimated from the glucose and insulin concentrations measured during the oral glucose tolerance test. Sex steroids will be measured as previously described.

Fat mass, lean mass and body fat depots will be measured as previously described. Circulating HDL-cholesterol and phospholipid levels will be measured by enzymatic methods after precipitation of plasma with phosphotungstic acid and Mg2+. Total cholesterol and triglyceride levels will be determined by enzymatic methods. LDL-cholesterol concentrations will be estimated by Friedewald's equation. Circulating apolipoprotein (Apo) AI, Apo B100, and lipoprotein (a) levels will be determined by kinetic immunonephelometry. Sex steroids will be measured as previously described.

Fat mass, lean mass and body fat depots will be measured as previously described. Office blood pressure will be determined as the mean of three manual sphygmomanometer readings in the sitting position. Sex steroids will be measured as previously described.

Fat mass, lean mass and body fat depots will be measured as previously described. Twenty-four-hour ambulatory blood pressure monitoring will be performed using an A\&D TM2430EX oscillometric device (A\&D Co., Ltd., Tokyo, Japan). The cuff (12 × 22 cm for lean participants, 14 × 30 cm for overweight or obese participants) will placed on the nondominant arm in every woman. The period from 0700 to 2300 h will be considered daytime, and from 2300 until 0700 h the next day will be considered nighttime, reflecting the usual sleeping habits of Spaniards. Systolic, diastolic, and mean blood pressure as well as heart rate will be measured every 20 min during daytime and every 30 min during nighttime. Sex steroids will be measured as previously described.

Fat mass, lean mass and body fat depots will be measured as previously described. Cardiovascular autonomic function will be assessed by the blood pressure and heart rate responses to active standing, and Ewing and Clarke's tests. Sex steroids will be measured as previously described.

Fat mass, lean mass and body fat depots will be measured as previously described. Imaging will be conducted using a high-resolution 7.5-MHz phased-array transducer by the same trained operator in all the participants. Sex steroids will be measured as previously described.

Fat mass, lean mass and body fat depots will be measured as previously described. Oxidative stress profile will be measured by enzymatic assays: Plasma thiobarbituric acid reactive substances, total antioxidant capacity, nitrotyrosine, protein carbonyl groups and erythrocyte glutathione peroxidase levels. Sex steroids will be measured as previously described.

Participants will be instructed to collect fecal and salivary samples. DNA samples wil be used for massive sequencing of 16S ribosomal DNA (rDNA) amplicons in a MiSeq platform (Illumina). The bacterial diversity will be estimated by using Shannon, Chao 1, Jaccard, and Sorensen indexes with their SDs. Taxonomic affiliations will be assigned by using the RDP_classifier from the Ribosomal Database Project (RDP), and readings with RDP score value \<0.8 will be assigned to the upper taxonomic rank, leaving the last rank as unidentified. Sex steroids will be measured as previously described.

Instituto de Salud Carlos III

University of Alcala

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Retroperitoneal Neoplasms

Abdominal Neoplasms

A standard dose of SonoVue ultrasound contrast agent is injected prior to the biopsy, and the percutaneous biopsy is guided in real time, targeting the contrast-enhanced areas of the retroperitoneal tumors (viable, vascularized)

CEUS-guided percutaneous biopsy

Standard of care (B-mode) ultrasound-guided percutaneous biopsy, without contrast enhancement

B-mode US-guided percutaneous biopsy

Zeno Spârchez, MD, Prof.

Background: Retroperitoneal tumors are typically large and inhomogeneous, with a variable amount of necrosis within the tumor mass which decreases the diagnostic yield of biopsy (false negative or inadequate).

Rationale: Real-time contrast enhancement can highlight the viable tumoral tissue and avoid the necrotic area.

Aims: To compare contrast-enhanced ultrasound (CEUS) guidance and conventional (B-mode) ultrasound (US) guidance in terms of diagnostic yield, need for repeat biopsy, and rate of adverse events.

Methods: A consecutive series of patients with previously documented retroperitoneal tumors and indications for percutaneous biopsy were randomly assigned to benefit from the standard of practice B-mode US-guided biopsy or CEUS-guided biopsy.

The diagnostic accuracy, need for repeat biopsy, and adverse events were noted.

Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors

Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors - a Randomized Controlled Trial

Bleeding, hematoma, puncture-site infection, prolonged hospitalisation

Institutul Regional de Gastroenterologie & Hepatologie Prof. dr. Octavian Fodor

Iuliu Hatieganu University of Medicine and Pharmacy

Principal Investigator

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Ernest Scalzetti, MD

Needle biopsy is a way of determining whether a lung mass is cancerous or benign. Its accuracy was established by research in which patients underwent fine needle aspiration, a kind of needle biopsy that yields samples for cytology (similar to the way a pap smear or a fluid sample would be evaluated for malignant cells). This kind of needle biopsy may supplemented or replaced by core needle biopsy, which yields samples for histology (similar to surgical tissue samples but on a smaller scale) rather than for cytology. Core needle biopsy is believed to be helpful particularly in obtaining a diagnosis in patients who have a lung mass that their doctors think is cancerous but is, in fact, benign. In spite of the advances in needle biopsy, however, there are patients who do receive a pathology report indicating no evidence of cancer but whose lung mass actually is cancerous. The fraction of such patients, among all patients who have no evidence of cancer according to the biopsy, is called the "false negative rate." It is approximately 25% for needle biopsies that consist of fine needle aspiration alone. The false negative rate for needle biopsies that include core biopsy samples is not known.

We want to examine the accuracy of needle biopsy in patients who had core samples taken from a lung mass in addition to, or in place of, fine needle aspiration. In this study we will focus on such patients who had no evidence of cancer according to the biopsy, to determine how many actually had a cancer that was missed by the biopsy. To accomplish this goal, we will need to review the medical records of these patients for one of two things: either a definitive diagnosis of the lung mass by some other means (for example, surgical biopsy), or by seeing how the patient does over a period of time (usually in conjunction with medical imaging tests such as chest x-rays or chest CT scans). To establish that a lung mass is benign by observing a patient over time, it is necessary to show that the lung mass disappears, becomes smaller, or remains unchanged in size for 2 years.

We will review medical records to identify patients who underwent percutaneous needle biopsy of a lung mass between 5/1/01 and 10/30/04. If the pathology report indicates that the biopsy showed no evidence of malignancy, we will examine the medical record for a "gold standard" diagnosis of the lesion in question, including the pathology result from a surgical resection or a repeat biopsy, imaging follow-up demonstrating regression of the lesion or size stability for at least 2 years, or clinical follow-up for at least 2 years with no clinical evidence of malignant disease. If this information is not available in the University Hospital medical record, we will contact the patient to obtain consent for follow-up using external sources (physician records, imaging studies, pathology reports).

We will derive descriptive statistics (prevalence of malignancy, sensitivity, specificity, and false negative rates). The overall sample size will be \~500 patients who had PTNB of a lung mass within the study period. Approximately 80 are expected to have a biopsy result showing no evidence of malignancy, based on a retrospective review performed under an IRB exemption (87-04, letter dated 9/28/04). The expected proportion of cases with no evidence of malignancy is approximately 0.15. For a 95% confidence interval of 0.15+/-0.075 we will need follow-up information from 61 patients, considering that this is a descriptive study with a dichotomous variable. This gives us a margin for patients who will be lost to follow-up

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
XACT ACE Observational Registry	NCT04950959	Tumors	Hands-free, use...	18 Years -	Xact Robotics Ltd.
Body Fat as Determinant of Female Gonadal Dysfunction	NCT03841981	Polycystic Ovar... Hypothalamic Am...	Anthropometric ... Indirect calori... Biochemical, ho... Sonographic stu... 24-hour Ambulat... Percutaneous bi... Cardiovascular ... Oral smear and ...	18 Years - 40 Years	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors	NCT05659433	Retroperitoneal...	CEUS-guided per... B-mode US-guide...	18 Years -	Iuliu Hatieganu University of Medicine and Pharmacy
Contrast-enhanced vs. B-mode Ultrasound-guided Percutaneous Biopsy of Retroperitoneal Tumors	NCT05659433	Retroperitoneal...	CEUS-guided per... B-mode US-guide...	18 Years -	Iuliu Hatieganu University of Medicine and Pharmacy
False/Negative Rate of Lung Percutaneous Needle Biopsy	NCT00638352	Lung Neoplasm		18 Years -	State University of New York - Upstate Medical University

Spots Global Cancer Trial Database for percutaneous biopsy