Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

All Drugs and Chemicals

Fluorophosphate

Protective Agents

SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.

SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.

Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

ISB dye and standard white light imaging

Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.

ICG dye and FireFly fluorescence imaging

Robert Holloway, MD

The investigators hypothesis is that if sensitivity and specificity are found to be significantly higher than the current reports with Technesium-99 and ISB colorimetric dye, SLN biopsies might allow omission of full lymphadenectomy in lower-risk cases, thereby limiting peri-operative morbidity. SLN biopsies might also improve the detection of metastatic disease, essentially lowering the recognized false-negative rate of standard lymphadenectomy analyzed by routine H\&E pathologic analysis.

The study objective is to compare two sentinel lymph node detection technologies \[fluorescence imaging and Indocyanine Green (ICG) dye verses standard laparoscopic colorimetric analysis using Isosulfan Blue (ISB) dye\] for sensitivity and specificity of detecting metastatic disease in pelvic lymph nodes of women with endometrial cancer undergoing robotic-assisted laparoscopic hysterectomy and lymphadenectomy. The following three specific aims would be addressed in this research proposal:

Specific Aim 1: To determine the ability of mapping bilaterally pelvic SLN in women with endometrial cancer undergoing robotic-assisted laparoscopic staging comparing two different methods (i.e., comparing the combination of colorimetric analysis-ISB dye + fluorescence imaging-ICG dye vs. colorimetric analysis-ISB dye alone).

Specific Aim 2: To estimate the negative predictive value (NPV) of pelvic SLN in endometrial cancer with respect to predicting nodal metastasis.

Specific Aim 3: To evaluate the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H\&E) results.

Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG

Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue (ISB) and Indocyanine Green Dyes (ICG) With Fluorescence Imaging

Of the 127 positive nodes with pathology information, the percentage of each type of node will be summarized by the staining method. Statistical testing of the individual staining methods compared to both will be computed using Chi-square test of independence.

The standard definition for negative predictive value was used to calculate NPV. There was one false negative SLN in this study, 39 true positive sentinel lymph nodes, and 140 negative pelvic metastatic patients.

NPV = 140/141=99.3%

AdventHealth

ISB only Adverse Events categories reported during post-op follow up 6 weeks

ISB Only Adverse Events

ICG Adverse Events categories reported during post-op follow up 6 weeks

ICG Adverse Events

SLN mapping utilizing da Vinci surgical system with Isosulfan Blue (ISB) dye and standard white light imaging.

ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

ISB Dye, Standard White Light

SLN mapping utilizing da Vinci surgical system with ISB dye and standard white light first, and then additionally, Indocyanine Green (ICG) dye and FireFly fluorescence imaging.

ISB dye and standard white light imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.

ICG dye and FireFly fluorescence imaging: Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.

ICG Dye, FireFly Fluorescence Imaging

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Robert W. Holloway

The ISB dye alone group (n=20) and the ICG group (n=180) are combined, because both groups received the ISB dye.

Number of Pelvic Sentinel Lymph Nodes (SLN) in Endometrial Cancer Patients Detected by Either ICG and/or ISB Dyes.

Metastatic Disease

Non Metastatic Disease

Experimental subjects with Indocyanine Green (ICG) negative test results

ICG Negative

Experimental subjects with Indocyanine Green (ICG) positive test results

ICG Positive

Comparison of metastatic disease (yes or no) with ICG dye node detection (yes or no)

Negative Predictive Value (NPV) of Pelvic SLN in Endometrial Cancer in Relation to the Number of Nodes With Metastasis.

Sentinel Nodes

Pelvic Nodes Only

Aortic

Infrarenal

Positive node identified with IHC dye only

IHC Only

H&E Only

Positive node identified with both IHC and H\&E dye

Both IHC and H&E

Number of Pelvic Sentinal Lymph Nodal Metastasis in Regard to Staining by Immunohistochemical (IHC) Staining in Comparison to Standard Hematoxylin and Eosin (H&E).

Overall Study

Uterine Cervical Neoplasms

Carcinoma

Uterine Cervical Diseases

Tissue from SLNs removed from early-stage cervical cancer patients are analyzed for HPV.

HPV analysis

Sara Bønløkke Simonsen

Katrine Fuglsang, PhD

This study examines sentinel lymph node tissue from early stage cervical cancer patients treated with radical hysterectomy and removal of pelvic sentinel lymph nodes (SLN). SLNs are tested for the presence of human papilloma virus (HPV), and results are compared to the HPV-type found in the patients cervical tissue.

We hereby examine whether pathologic status of SLNs in patients with early-stage cervical cancer correlates to the HPV status in the SLNs. By means of an up to 5-years follow-up period, we furthermore examine whether cervical cancer recurrence correlates to the histopathologic status of the SLNs and/or the SLN HPV status. This will contribute to the clarification on whether HPV status of the SLNs plays a crucial role for predicting LN metastasis of cervical cancer and also, whether the HPV status in SLNs may have a clinical value as a prognostic factor for disease recurrence in cervical cancer patients and perhaps even a better clinical value than SLN mapping.

The aim of the study is to examine whether the pathologic status of SLNs in patients with early-stage cervical cancer correlates to the HPV status in the SLNs and also, whether cervical cancer recurrence correlates to the histopathologic status of the SLNs and/or the SLN HPV status.

In Denmark, staging and treatment of cervical cancer are performed according to the recommendations of the International Federation of Gynecology and Obstetrics (FIGO). Cervical cancer is the only gynecological cancer that is clinically based on tumor size, vaginal or parametrial involvement, bladder/rectum extension and distant metastases. It requires examination under anesthesia and imaging, which in Denmark includes positron emission computed tomography (PET-CT) to detect pathological lymph nodes (LNs) and to accurately delineate the extent of the disease and magnetic resonance imaging (MRI) to determine tumor size, degree of stromal penetration, parametrial involvement, vaginal and corpus extension. Tumor risk assessment includes tumor size, stage, depth of tumor invasion, LN status, lymphovascular space invasion (LVSI) and histological subtype, of which LN status and number of LNs involved are the most important prognostic factors. In Denmark, patients at FIGO stages 1B1 to 2A undergo radical hysterectomy and radical pelvic lymphadenectomy (PL), and they are offered adjuvant oncological treatment with radiotherapy and concomitant chemotherapy if specific risk factors are present. A national protocolled study on the implementation of SLN mapping in women with early-stage cervical cancer is currently being conducted in Denmark at Rigshospitalet, Odense University Hospital and Aarhus University Hospital (The Sentirec study). In this study, we want to examine the remains from these analyzed SLNs. According to the Sentirec protocol, SLNs are examined by means of ultrastaging, which entails cutting the SLNs in more sections and all levels of the LN and examining these levels histologically by an experienced pathologist. In this study, we examine the remains from the SLNs; that is the sections between the tissue used for SLN mapping. These sections are analyzed for HPV.

Early-stage cervical cancer patients treated with radical hysterectomy and removal of SLNs.

Early-stage cervical cancer patients admitted for surgery with radical hysterectomy and removal of SLNs.

HPV in Sentinel Lymph Nodes

HPV-testing of Sentinel Lymph Node Tissue From Cervical Cancer Patients.

University of Aarhus

Skin and Connective Tissue Diseases

Rare Diseases

Breast Neoplasms

Melanoma

Breast Diseases

Skin Diseases

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Neuroendocrine Tumor

Neuroepithelioma

Participant received a single dose of 0.2 milligrams (mg) intradermal injection of ASP5354 on day 1.

pudexacianinium chloride

Medical Monitor

This study was for women with breast cancer and for adults with melanoma. Breast cancer was a type of cancer when cells in the breast turn into cancer cells, which might grow out of control. Melanoma was a type of skin cancer that starts in cells called melanocytes. These cells made a substance called melanin which gives the skin its color. In this study, people had surgery to remove the lymph node closest to the site of their cancer. This lymph node was called the sentinel node. This was done to check if the cancer had spread from the original site to the sentinel node. This procedure was called a sentinel node biopsy.

This study provided more information on a potential new dye, called ASP5354, used in sentinel node biopsies. ASP5354 helped to show the lymph nodes more clearly during surgery. This helped the surgeon find the lymph node closest to the site of the cancer (sentinel node).

The main aim of the study was to find the best dose of ASP5354 that clearly showed the lymph nodes during surgery. This was an open-label study. That means each person in the study and the study doctors knew that person received ASP5354.

Each person only received 1 dose of ASP5354.

People that wanted to take part in the study were checked by a study doctor. This was on a separate visit before their surgery. Before surgery, people who took part in the study were asked if they had any other medical problems. They had a physical exam, an ECG to check their heart rhythm, and had their vital signs checked (blood pressure, pulse rate, and breathing rate). Other checks included some blood and urine samples taken for laboratory tests.

During surgery, a study surgeon injected ASP5354 near the cancer site. They recorded how clearly they could see the lymph nodes. Some blood samples were taken for laboratory tests and an ECG was done. After their surgery, people were asked if they have any other medical problems.

People returned to the hospital 9 days later for a check-up. The check-up included a physical exam, an ECG to check their heart rhythm, and a check of their vital signs (blood pressure, pulse rate, and breathing rate). Other checks included some blood samples taken for laboratory tests. People were asked if they had any medical problems and asked to complete a feedback survey.

A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery

A Phase 2 Open-label, Dose-finding Study to Determine the Optimal Dose for Lymph Node Visualization Using ASP5354 in Participants With Breast Cancer or Melanoma Undergoing Sentinel Lymph Node Biopsy

Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.

The optimal dose was defined as the dose that provided a better visualization compared with lower doses and a comparable visualization to the next higher dose. In the case where 2 doses performed equally, the lower dose was selected. Cumulative visualization data of the LNs from all treated participants was used for optimal dose determination. The optimal dose was determined by the Visualization Review Committee (VRC) using data from the following assessments: LN tissue visualized (Y/N), visualized tissue is lymphatic in origin based on pathologic confirmation, Likert Scale determination of the intensity of fluorescence, and proportion of identified LN with histopathologic confirmation of LN tissue by ASP5354 compared with standard of care (SOC) treatment.

The visualization of at least 1 LN with histopathologic confirmation is assessed by using a binary "Yes" or "No" question. Those participants with "Yes" as response was reported.

The percentage of identified LN with ASP5354 will be compared with SOC treatment with either Tc-99mSC or Lymphoseek, through histopathologic confirmation.

An AE was defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE could therefore be any unfavorable \& unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An AE was considered "serious" if, it resulted in any of the following outcomes: results in death; is life-threatening; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; results in congenital anomaly, or birth defect; requires inpatient hospitalization; or leads to prolongation of hospitalization; other medically important events. TEAE was defined as an AE observed after starting administration of the study drug.

Plasma concentration of ASP5354. The Lower limit of quantification (LLOQ) was defined as 1.00 nanograms per milliliter (ng/mL). Measured values below the LLOQ were expressed as \<LLOQ and not reported.

Astellas Pharma Inc

Participant received a single dose of 0.2 mg intradermal injection of ASP5354 on day 1.

ASP5354 0.2 mg

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Full analysis set (FAS): Participant enrolled and received study Investigational product (IP).

Clinical Trial Disclosure

Optimal Dose of ASP5354 for Lymph Node (LN) Visualization

Percentage of Participants With at Least 1 LN Detected Using ASP5354

Percentage of Identified LN Tissue by ASP5354 Compared With SOC Treatment

TEAE

Safety Analysis Set (SAF): Participant enrolled and received study IP.

Number of Participants With Treatment Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

Predose

10 minutes post dose

30 minutes post dose

60 minutes post dose

End of surgery post dose

Pharmacokinetic analysis set: All participants who received at least 1 dose of IP for which at least 1 plasma concentration data were available with the time of dosing and sampling.

Plasma Concentration of ASP5354

ASP5354 0.2 Milligrams (mg)

Participants receive a subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension (OPTISON™). Ultrasound images and videos of tumor and lymph nodes in underarm area taken. Biopsy of sentinel lymph node that was identified in ultrasound performed, and a titanium clip marker inserted into the node. After biopsy, a radioactive seed may be inserted into the node to allow surgeon to find and remove it during surgery. Participant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes.

Participants receive a subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension (OPTISON™) before breast ultrasound.

Perflutren Protein-Type A Microspheres Injectable Suspension

Ultrasound images of breast and videos of tumor and lymph nodes in underarm area taken after Perflutren Protein-Type A Microspheres Injectable Suspension injection.

Contrast-Enhanced Ultrasound (CEUS)

Biopsy of sentinel lymph node that was identified in ultrasound performed, and a titanium clip marker inserted into the node. After biopsy, a radioactive seed may be inserted into the node to allow surgeon to find and remove it during surgery.

Biopsy + Radioactive Seed Placement

Participant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes.

Phone Call

Basak Dogan, MD

The goal of this clinical research is to learn if an ultrasound contrast agent called OPTISON (perflutren protein type A) is effective in finding sentinel lymph nodes before surgery. Contrast agents can help make ultrasound images more accurate. The sentinel lymph node is the first node that may be the target of cancer cells that spread from the tumor.

Study Procedures:

If you agree and are eligible to take part, you will receive perflutren protein type A by injection under the skin near the nipple. After you receive the injection, the radiologist will take more ultrasound images and videos of the tumor and lymph nodes in the underarm area.

You will have a biopsy of the sentinel lymph node that was identified in the ultrasound and a titanium clip marker will be inserted into the node. The clip helps distinguish the biopsied node from other nodes. You will be told the results of biopsy. After the biopsy, a radioactive seed may be inserted into the node to allow the surgeon to find and remove it during your surgery, an extra node may be removed at that time.

You will still have standard of care sentinel lymph node biopsy during your already scheduled surgery. You will sign a separate surgical consent form that explains this procedure and its risks.

You will be called by phone 30 days after the seed is removed to check for any side effects. This phone call should take about 10 minutes.

Length of Study:

Your active participation in this study will be over the follow up phone call.

This is an investigational study. Perflutren protein type A is FDA approved and commercially available for use in contrast-enhanced echocardiograms. Its use in this study is investigational.

Up to 21 patients will take part in this study. All will be enrolled at MD Anderson.

Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients

Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Ultrasound Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients

Following the Microbubble CEUS of ipsilateral axillary nodes, needle biopsy and I-125 seed placement, a single node/participant (biopsied node) will be included in the statistical evaluation. The technique determined as technically feasible if an enhancing node is visualized in at least 90% of the subjects and 80% concordance is achieved between imaging-guided biopsy and final surgical histopathology. If no enhancement is identified, the overlying skin will be massaged, and re-injection of contrast will be employed up to three times. If no contrast enhancement in lymphatics is observed, the case will be reported as a failure of the CEUS technique.

GE Healthcare

M.D. Anderson Cancer Center

Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node biopsy and radioactive seed placement.

CEUS Sentinel Lymph Node Imaging + Guided Biopsy

Age, Continuous

Dr. Basak Dogan/Diagnostic Radiology

Number of Breast Cancer Participants With Sentinel Lymph Nodes (SLN) Identification Using the CEUS Technique

Subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension before Contrast-Enhanced Ultrasound (CEUS), sentinel lymph node (SNL) biopsy and radioactive seed placement.

CEUS SNL Imaging + Guided Biopsy

Methylene Blue

Enzyme Inhibitors

Methylene blue (1%)

Rhenium sulfure

Surgical procedure

Anatomo-pathologic procedure

Jean-Pierre Bellocq, MD

The aim of this study is to evaluate the performance of a double labelling method using isotope and methylene blue dye injection to localize precisely Sentinel Lymph Node (SLN) in a series of 100 patients with infiltrative breast cancer justifying SLN excision. Method and patients: SLN excision will be performed on 100 patients treated for infiltrative breast cancer. After preoperative methylene blue dye injection and lymphoscintigraphy, individual localization of the radioactive and stained nodes will be performed. After the surgery, SLN will be submitted to serial analysis and immunohistochemistry. A comparison of the two methods and an economical evaluation of the complete procedure will be performed.

Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope

Identification of Sentinel Lymph Node (SLN) in Breast Cancer Care: Clinical and Economical Evaluation of a Double Method Using Isotope and Methylene Blue Dye Injection.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG	NCT02068820	Endometrial Can...	ISB dye and sta... ICG dye and Fir...	18 Years - 85 Years	AdventHealth
HPV in Sentinel Lymph Nodes	NCT03749707	Cervical Cancer Sentinel Lymph ... HPV-Related Cer...	HPV analysis	18 Years -	University of Aarhus
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery	NCT05457842	Sentinel Lymph ... Breast Cancer Melanoma	pudexacianinium...	18 Years -	Astellas Pharma Inc
Feasibility of Ultrasound Microbubble Contrast-Enhanced (CEUS) Sentinel Lymph Node Imaging With Guided Biopsy in Breast Cancer Patients	NCT02321527	Breast Cancer	Perflutren Prot... Contrast-Enhanc... Biopsy + Radioa... Phone Call	18 Years -	M.D. Anderson Cancer Center
Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope	NCT00314405	Infiltrative Br...	Methylene blue ... Rhenium sulfure Surgical proced... Anatomo-patholo...	18 Years -	University Hospital, Strasbourg, France
Identification of Sentinel Lymph Nodes With Methylene Blue and Isotope	NCT00314405	Infiltrative Br...	Methylene blue ... Rhenium sulfure Surgical proced... Anatomo-patholo...	18 Years -	University Hospital, Strasbourg, France
A Study to Find the Best Dose of ASP5354 to Show Lymph Nodes in People With Breast Cancer or Melanoma During Surgery	NCT05457842	Sentinel Lymph ... Breast Cancer Melanoma	pudexacianinium...	18 Years -	Astellas Pharma Inc
Detection of SLN in Patients With Endometrial Cancer Undergoing Robotic Assisted Staging: Comparison of ISB and ICG	NCT02068820	Endometrial Can...	ISB dye and sta... ICG dye and Fir...	18 Years - 85 Years	AdventHealth

Spots Global Cancer Trial Database for sln

Every month we try and update this database with for sln cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sln

Every month we try and update this database with for sln cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sln cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.