Heart and Blood Diseases

All Conditions

Rare Diseases

Phlebitis

Vascular Diseases

Peripheral Arterial Disease

Peripheral Vascular Diseases

Vasculitis

SeSAME Syndrome

Pharmaceutical Solutions

All Drugs and Chemicals

This arm will be administered 2 drops of sesame oil daily along the channeled vein, about 3 centimeters from the insertion point.

This arm will be administered 2 drops of physiological saline daily along the channeled vein, about 3 centimeters from the insertion point.

A peripheral venous catheter will be channeled to the patient admitted to the unit and who requires it. The indications included in the guide for channeling venous access of the Marqués de Valdecilla hospital will be followed.

Once the venous access has been channeled, it will be fixed with, leaving the puncture point visible for future monitoring.

The sesame oil chosen for the project is "Sesame bio - 100% pure vegetable oil from the Naissance brand.

To perform the procedure, two drops of sesame oil will be applied daily by the nurse in charge of the patient during the morning shift in the area about 2 cm above the insertion point and coinciding with the course of the vein channeled for intravenous therapy. A small massage of the area of application will be performed, with an approximate extension of 3x3cm, until its absorption. It will be left to dry in the air.

Sesame oil

After cannulation of the vein following the same procedure as explained in the intervention arm, patients belonging to the control arm will be administered two drops of saline solution.

Saline solution

Virginia Meneses Campos

Virginia Meneses

Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.

For the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. These peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis.

Phlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward.

Phlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism.

The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.

With the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance of phlebitis.

Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial.

Effects of Topical Sesame Oil in the Prevention of Chemotherapy-associated Peripheral Venous Catheter Phlebitis: Clinical Trial.

Sesame oil will be applied in the intervention groups, with the aim of assessing whether its application decreases the occurrence of phlebitis in oncology patients with irritating and high osmolarity intravenous medication.

Registration of other adverse effects related to chemotherapy administration through a peripheral catheter: extravasation, number of cannulations during admission, catheter duration and reason for withdrawal.

Hospital Universitario Marqués de Valdecilla

Principal Investigator

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Prostatic Neoplasms

Adenocarcinoma

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Gallium 68 PSMA-11

Radiopharmaceuticals

Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. One to 14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.

Angiogram

Undergo prostatic arterial catheterization

Catheterization

Gallium Ga-labeled PSMA-11

Positron Emission Tomography

Ryan Kohlbrenner

Prostate-specific membrane antigen (PSMA) agents have shown promise in detecting and treating prostate cancer. Gallium-68-labeled PSMA-11 (68Ga-PSMA-11) is a radioactive agent that binds to prostate cancer cells and can be imaged using positron emission tomography (PET) scanners that detect radioactivity in the body. This early phase I study will use PET to determine if delivering 68Ga-PSMA-11 directly into the prostatic artery (intra-arterial (IA) administration) results in greater uptake in the prostate than delivering 68Ga-PSMA-11 into a vein in the arm (intravenous (IV) administration).

PRIMARY OBJECTIVE:

I. To compare the maximum standardized uptake value (SUVmax) in tumoral regions-of-interest during prostatic arterial and intravenous 68Ga-PSMA-11 infusions.

SECONDARY OBJECTIVES:

I. To compare the tumoral time-activity curves for selective prostatic arterial and intravenous 68Ga-PSMA-11 infusions.

II. To study PSMA receptor saturation kinetics during selective prostatic arterial infusion of 68Ga-PSMA-11 (obtained only from arterial time activity curves \[TACs\] ipsilateral to the side of infusion).

OUTLINE:

Patients receive 68Ga-PSMA-11 IV over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after on day 1. 1-14 days later, patients undergo pelvic angiogram and prostatic arterial catheterization. Patients then receive 68Ga-PSMA-11 IA over 30 minutes and undergo dynamic PET imaging over infusion period and for 15 minutes after.

After completion of study, patients are followed up with 24 hours after the IA infusion and PET scan.

Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion

Pharmacokinetic Comparison of Selective Prostatic Arterial and Intravenous PSMA Radioligand Infusions in Treatment-Naïve Prostate Cancer Patients

A two-sided paired t-test will determine whether the ipsilateral SUVmax values obtained during selective arterial 68Ga-PSMA-11 infusions are greater than those obtained during venous infusions. A similar paired analysis will be made during arterial infusions to compare tumoral regions of interest (ROIs) ipsilateral and contralateral to the side of the infusion. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Paired t-tests will determine whether SUVmean is different for intra-arterial (IA) time activity curves (TACs) when compared to intravenous (IV) TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Paired t-tests will determine whether TSUV is different for IA TACs when compared to IV TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Paired t-tests will determine whether AUCs are different for IA TACs when compared to IV TACs. Means/medians, ranges/standard deviations will be calculated for each endpoint.

To assess whether the rate of uptake is significantly different with selective arterial infusion, a two-sided paired t-test will compare the slopes for Selective arterial infusion, tumor ipsilateral to the side of radiotracer injection (IAIpsi) curves and Intravenous infusion, tumor ipsilateral to the side of corresponding arterial injection (IVIpsi) curves during each of the nine time intervals. Selective arterial infusion, tumor contralateral to the side of radiotracer injection (IACont) slopes will be similarly compared to those acquired from corresponding Intravenous infusion, tumor contralateral to the side of corresponding arterial injection (IVCont) data. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Specific to the IAIpsi TACs, the time to early saturation effects (Tese) will represent the time at which the second derivative of the curve becomes negative (i.e. when concavity in the curve is first noted). For the purposes of Tese, the aforementioned curve partitioning method will not be used. Descriptive statistics of Tese will be established, along with statistics for the corresponding mass dose administered (MDese) at Tese. Means/medians, ranges/standard deviations will be calculated for each endpoint.

Descriptive statistics of Tese will be established, along with statistics for the corresponding mass dose administered (MDese) at Tese. Means/medians, ranges/standard deviations will be calculated for each endpoint.

The mean SUVwashout and its standard deviation will be calculated for the 15-minute post-injection periods.

Radiological Society of North America

Ryan Kohlbrenner, MD

Digestive System Diseases

Esophageal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Head and Neck Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Central Nervous System Depressants

Analgesics

Adjuvants, Anesthesia

Antiemetics

Gastrointestinal Agents

Anesthetics

Ropivacaine

Anesthetics, Local

Sufentanil

Granisetron

Dsuvia

Dezocine

Patients were given continuous RISS plane block in addition to patient controlled intravenous analgesia.

Patients were given single RISS plane block in addition to patient controlled intravenous analgesia.

Patients were given patient controlled intravenous analgesia.

Before the operation,the patient was placed in the left lateral position.The catheter（soft tip epidural catheter 20-gauge-100 cm） was placed at the rhomboid-intercostal plane under ultrasound guidance at the T5-T6 level, followed by ultrasound-guided catheter placed in the anterior serrated muscle plane at the T7-9 level。

Before the operation,40milliliters of 0.3% ropivacaine was injected into the rhomboid-intercostal fascia plane and anterior serrated muscle plane respectively under the guidance of ultrasound.

Single nerve block

After surgery,local anesthetics were injected continuously through catheters.Local anesthetic formula:Ropivacaine 300mg + normal saline, prepared into 150milliliters liquid, background dose 2milliliters/h.

Continuous nerve block

After surgery, the patient was given controlled intravenous analgesia. Analgesic pump drug formula:Sufentanil 50ug+ Dezocine 20mg+ Granisetron 10mg+150milliliters saline, continuous dose of 2milliliters/h intravenous pump, single injection dose of 2milliliters, locking time of 20 min

PCIA

Luo fuchao, MD

The objective is to investigate the safety and effectiveness of rhomboid intercostal and subserratum plane (RISS) block for postoperative analgesia after minimally invasive McKeown esophagectomy (MIE-McKeown).

Rhomboid intercostal and subserratum plane block (RISS) is a nerve block technique in which local anesthetics are injected into the rhomboid-intercostal muscle planes and the serratus anterius-intercostal muscle planes, and the intercostal nerve is blocked by diffusion of local anesthetics. It is confirmed that RISS can provide analgesia not only in the front half of the chest, but also in the upper abdomen. However, the efficacy of RISS in minimally invasive surgery for esophageal cancer has not been proven. The investigators placed catheters on the RISS plane and continuously injected local anesthetics to investigate whether RISS is effective and safe in minimally invasive esophageal cancer surgery.

Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy

Clinical Study of Rhomboid Intercostal and Subserratum Plane Block for Postoperative Analgesia in Minimally Invasive Esophagectomy

patient will be asked to rate their pain level at rest and cough respectively using visual analogue scale（VAS）.(0 being no pain, 10 being worst pain imaginable)

The mean arterial pressure (MAP)on the monitor at different times was recorded.

The Heart rate (HR)on the monitor at different times was recorded.

The occurrence of nausea /vomiting was recorded

The occurrence of hypotension was recorded

The occurrence of respiratory depression was recorded

The occurrence of urinary retention was recorded

patient will be asked to rate their Satisfaction with analgesia using verbal rating scales (VRS) .Scores from 1 to 5 represent very dissatisfied, not satisfied, basically satisfied, relatively satisfied, and very satisfied with the analgesic effect, respectively.

Luo Fuchao

principal

Liver Neoplasms

Hematinics

Liver Extracts

Study participants will be enrolled in the Device Arm and the Vu-Path™ Device will be used to access the femoral artery for intra-arterial chemoembolization.

Femoral arterial access in eligible participants will be performed using the Vu-Path™.

Vu-Path™

Robert Liddell, MD

This first-in-human pilot study seeks to evaluate the feasibility and safety of using a percutaneous ultrasound device with needle guide for vascular access. Eligible participants will undergo the procedure of transcatheter arterial chemoembolization for primary or metastatic liver cancer, as part of participants' clinical care. The percutaneous ultrasound device with needle guide will be deployed in eligible participants at the beginning of the procedure for guiding a needle inside the femoral artery. Once the needle is inside the artery, then a guide wire is advanced inside the needle and vascular access is successfully obtained.

The study will identify whether this ultrasound-based device with needle guide is helpful for guiding a needle inside the femoral artery.

This NIH Small Business Innovation Research (SBIR)-funded study seeks to test a forward-viewing, ultrasound (US)-based device with needle guide for vascular access.

Access to large arteries is an indispensable step of any trans-arterial catheterization procedure. Surface US-guided vascular cannulation greatly improves first-pass success and reduces complications and is recommended as the preferred technique by numerous specialties and governmental agencies. Surface US-guided cannulation has several key limitations, including dependence on operator skills and experience. Safety and success of vascular access could be vastly improved with a single integrated imaging/interventional device with a small footprint that enables a single-hand operation of the US probe and visualizes the operating needle in real-time.

Reliable and accurate real-time image guidance for vascular access has the potential to appreciably impact public health by enhancing patient safety and convenience, improving procedural accuracy and increasing procedure throughput. Successful implementation has the potential to reduce care and complication costs across millions of vascular access procedures.

Vu-Path™ is a small footprint, US-based device with needle guide. It is a dual-lumen instrument with parallel US imaging and interventional lumens. The forward-viewing US transducer is located at the catheter tip and focused such that the tip of the needle in the interventional lumen, and all proximate structures, are always clearly visualized in real time throughout the procedure.

This is a first-in-human pilot study of the Vu-Path™ device, aiming to its establish clinical feasibility and safety for exemplary use.

A Percutaneous Ultrasound Device With Needle Guide for Vascular Access

Device Safety will be assessed by the number of participants experiencing minor bleeding resulting from vascular puncture. Minor bleeding is defined as either a) bleeding that requires no therapy, or has no consequences or, b) requires nominal therapy, or has no consequence or, c) includes overnight admission for observation only.

Device Safety will be assessed by the number of participants experiencing major bleeding. Major bleeding is defined as bleeding that either a) requires therapy and minor hospitalization (25-48 hours) or, b) requires major therapy, unplanned increase in level of care and prolonged hospitalization (\> 48 hours), or c) has permanent adverse sequelae or, d) results in death.

Percentage of first attempt accesses to target site.

Procedure time is defined as the total time needed for device procedure.

Target access time is defined as the total time needed from target visualization to target access.

Device usage time is defined as the total time needed for device use.

Perceptive Navigation LLC

National Heart, Lung, and Blood Institute (NHLBI)

Johns Hopkins University

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Primary Central Nervous System Lymphoma

Antineoplastic Agents

Antirheumatic Agents

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients may undergo catheterization, undergo leukapheresis, may receive fludarabine IV and cyclophosphamide IV, and receive CD19-CAR T cells ICV on study. Patients also undergo MRI, PET, CT, collection of blood samples, and CSF aspiration throughout the trial, and lumbar puncture as clinically indicated.

Aspiration

Biospecimen Collection

CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes

Computed Tomography

Leukapheresis

Lumbar Puncture

Magnetic Resonance Imaging

Tanya Siddiqi

This phase I trial tests the safety, side effects, and best dose of intracerebroventricularly (ICV) administered CD19-chimeric antigen receptor (CAR) T cells in treating patients with primary central nervous system (CNS) lymphoma. CAR T cell therapy is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient's blood. Then the gene for a special receptor that binds to a certain protein, CD19, on the patient's cancer cells is added to the T cells in the laboratory. The special receptor is called a chimeric antigen receptor (CAR). Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. ICV is an injection technique that delivers the CD19-CAR T cells directly into the cerebrospinal fluid (which flows in and around the hollow spaces of the brain and spinal cord, and the thin layers of tissue that cover and protect the brain and spinal cord) in the brain, through a surgically placed catheter. Giving CD19-CAR T cells ICV may be more effective at treating patients with primary CNS lymphoma than giving them via other methods.

PRIMARY OBJECTIVES:

I. Examine and describe the safety and feasibility of ICV delivery of CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes (CD19-CAR T cells) and determine the recommended phase 2 dose (RP2D) in participants with primary CNS lymphoma (PCNSL).

II. Determine the activity of ICV-delivered CD19-CAR T cells based on disease response at the maximum tolerated dose (MTD).

SECONDAY OBJECTIVES:

I. Describe persistence, expansion and phenotype of endogenous and CD19-CAR T cells in peripheral blood (PB), and cerebral spinal fluid (CSF), when available.

II. Describe cytokine levels (PB, CSF) over study period. III. Quantify B-cell aplasia over the treatment period as a surrogate for targeted cytotoxicity in the periphery.

IV. Assess prolonged cytopenia based on prolonged grade 4 continuous or intermittent anemia, neutropenia, thrombocytopenia, and hypogammaglobulinemia \> 60 days or deemed medically significant.

V. Estimate rates of disease response. VI Estimate rate of 6-month progression free survival (PFS6mon). VII. Estimate median overall survival (OS).

EXPLORATORY OBJECTIVES:

I. Characterize changes in potential molecular and gene-analysis based indicators of neurotoxicity in CSF and PB.

II. Describe the tumor phenotype pre- and post-therapy. III. Characterize functional and phenotypic metabolic profile of CAR T cells pre- and post-infusion.

IV. Assess the presence and magnitude of human anti-mouse antibody (HAMA).

OUTLINE: This is a dose-escalation study followed by a dose-expansion study.

Patients may undergo catheterization, undergo leukapheresis, may receive fludarabine intravenously (IV) and cyclophosphamide IV, and receive CD19-CAR T cells ICV on study. Patients also undergo magnetic resonance imaging (MRI), positron emission tomography (PET), computed tomography (CT), collection of blood samples, and CSF aspiration throughout the trial, and lumbar puncture as clinically indicated.

Intracerebroventricular Administration of CD19-CAR T Cells (CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes) for the Treatment of Primary Central Nervous System Lymphoma

A Phase 1 Study to Evaluate Intracerebroventricular (ICV) Administration of CD19-Targeting Chimeric Antigen Receptor (CAR) T Cells in Patients With Primary CNS Lymphoma

Will be assessed using the National Cancer Institute's Common Terminology Criteria for Adverse Events version 5.0, particularly dose-limiting toxicities (DLTs), cytokine release syndrome (CRS) based on the revised CRS grading system by American Society for Transplantation and Cellular Therapy Consensus Criteria, and all other toxicities. Rates and associated 90% Clopper and Pearson binomial confidence limits will be estimated for participants experiencing DLTs, each type of cytopenia, disease response and progression free survival (PFS) at 6 months. All toxicities and side effects will be summarized in tables by period, organ, severity and attribution.

Will be assessed per International Primary Central Nervous System Lymphoma Collaborative Group criteria.

Detected in peripheral blood (PB) and cerebral spinal fluid (CSF) when available, (absolute number per uL by flow). CAR T cell level and cytokines will be interrogated if CRS or neurotoxicity attributed at the probable level to CAR T cells are observed. Statistical and graphical longitudinal methods will be used to describe the profile of the CAR T cells, and endogenous immune cell populations including B cells through one-year post T cell infusion. Regression analysis will be used to assess the relationship between CAR T cell levels and B cells levels.

Measured in PB, and CSF, when available. CAR T cell level and cytokines will be interrogated if CRS or neurotoxicity attributed at the probable level to CAR T cells are observed. Cytokine levels (PB and CSF) will be described using longitudinal statistical and graphical methods over the study period.

Measured in PB. CAR T cell level and cytokines will be interrogated if CRS or neurotoxicity attributed at the probable level to CAR T cells are observed. Statistical and graphical longitudinal methods will be used to describe the profile of the CAR T cells, and endogenous immune cell populations including B cells through one-year post T cell infusion. Regression analysis will be used to assess the relationship between CAR T cell levels and B cells levels.

Measured in PB. Rates and associated 90% Clopper and Pearson Binomial confidence limits will be estimated for each type of cytopenia.

Patients are considered a failure for this endpoint if they die (regardless of cause) or experience disease relapse.

Kaplan Meier methods will be used to estimate median OS and graph the results.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial.	NCT06375850	Phlebitis	Sesame oil Saline solution	18 Years -	Hospital Universitario Marqués de Valdecilla
Pharmacokinetics of IA and IV Ga68-PSMA-11 Infusion	NCT04976257	Prostate Adenoc... Prostate Carcin... Stage IIC Prost... Stage III Prost... Stage IIIA Pros... Stage IIIB Pros... Stage IIIC Pros... Stage IV Prosta... Stage IVA Prost... Stage IVB Prost...	Angiogram Catheterization Gallium Ga-labe... Positron Emissi...	18 Years - 80 Years	University of California, San Francisco
Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial.	NCT06375850	Phlebitis	Sesame oil Saline solution	18 Years -	Hospital Universitario Marqués de Valdecilla
Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy	NCT06092944	Esophagus Cance...	Catheterization Single nerve bl... Continuous nerv... PCIA	18 Years - 75 Years	Fuling Central Hospital of Chongqing City
A Percutaneous Ultrasound Device With Needle Guide for Vascular Access	NCT03879161	Vascular Access	Vu-Path™	18 Years -	Johns Hopkins University
A Percutaneous Ultrasound Device With Needle Guide for Vascular Access	NCT03879161	Vascular Access	Vu-Path™	18 Years -	Johns Hopkins University
Rhomboid Intercostal and Subserratum Plane Block for Minimally Invasive Esophagectomy	NCT06092944	Esophagus Cance...	Catheterization Single nerve bl... Continuous nerv... PCIA	18 Years - 75 Years	Fuling Central Hospital of Chongqing City
Intracerebroventricular Administration of CD19-CAR T Cells (CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes) for the Treatment of Primary Central Nervous System Lymphoma	NCT05625594	Central Nervous...	Aspiration Biospecimen Col... Catheterization CD19CAR-CD28-CD... Computed Tomogr... Cyclophosphamid... Fludarabine Leukapheresis Lumbar Puncture Magnetic Resona... Positron Emissi...	18 Years -	City of Hope Medical Center

Spots Global Cancer Trial Database for catheterization