Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Every patient undergoing a PET CT at the time of diagnosis of muscle invasive bladder cancer from January 2005 to December 2017 in Bordeaux (Institut Bergonié and University Hospital).

PET CT

Bladder cancer is the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years.

Optimal staging of lymph nodes and metastasis is crucial for treatment decision of muscle invasive bladder cancer (MIBC).

Guidelines do not recommend FDG-Positron Emission Tomography (PET) Computed Tomography (CT), but rather CT for lymph node and metastatic staging, despite its low accuracy. We performed a retrospective analysis of patients undergoing PET CT for localized MIBC in two centers, to help define the utility of PET CT in this setting.

Background:

Bladder cancer is the second most frequent genito-urinary cancer, and the seventh cause of cancer mortality in France. Overall survival is poor, between 45 and 50% at 5 years. Curative treatment of muscle invasive urothelial carcinoma localized to the bladder includes cisplatin-based neoadjuvant chemotherapy, followed by radical cystectomy with lymph nodes dissection. Nonetheless, surgery indications depend on pre-operative staging regarding nodes and metastatic involvement.

Computed Tomography (CT) scan is the reference imaging study for loco-regional and metastatic staging. Lymph node involvement evaluation is based on morphologic criteria only. Its sensitivity lies between 30 and 53% and its specificity between 67 and 91%. Yet, optimal node staging is crucial for therapeutic decision.

FDG-Positron Emission Tomography (PET) CT, using both morphologic and functional criteria, could help for node staging in muscle invasive bladder cancer assessment, especially by detecting infracentimetric involved lymph nodes. Moreover, it could be useful for detecting distant metastasis.

Objective:

To evaluate the accuracy of the PET CT for lymph node staging and to determine the rate of treatment modification according to PET CT results

Methods:

Retrospective study based on the medical records of every patient undergoing a PET CT at the time of diagnosis of MIBC from 01/2005 to 12/2017 in Bordeaux (Bergonie Institute and University Hospital). PET CT could have been done before any treatment (PET 1) and/or after neo-adjuvant chemotherapy and before surgery (PET 2).

Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer

Description: Assess differences between planned management before knowing the FDG-PET CT results and treatment actually received.

Comparison of lymph nodes staging on PET CT (according to EORTC criteria) and lymph nodes staging on pathological report, according to the AJCC TNM Staging System for Bladder Cancer 8th ed., 2017.

Evaluation of the concordance rate between PET CT results (according to EORTC criteria) and CT scan results (according to RECIST 1.1) for lymph node and metastatic staging according to the AJCC TNM Staging System for Bladder Cancer 8th ed., 2017.

Comparison of PET-CT TNM staging between patients with and patients without a Pathological Complete Response

Comparison of Recurrence Free Survival for patients with and patients without a Complete Metabolic Response (according to EORTC criteria)

Institut Bergonié

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

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

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Micronutrients

All Drugs and Chemicals

Iron

Patients with melanoma of the extremities included in the protocol. Preoperative, patients will receive two MRI-scans and a magnetic tracer injection at the primary tumor site. During surgery, SLNs will be detected using two types of magnetometers (SentiMag® \& DiffMag) in combination with Magtrace®, in addition to the standard procedure.

In addition to the standard procedure, SLNs will be detected using two types of magnetometers (SentiMag® \& DiffMag) in combination with SPIO particles (Magtrace®).

Magnetic sentinel lymph node biopsy by use of Magtrace®, in combination with SentiMag® and DiffMag

Anke Christenhusz, MSc

Lejla Alic, PhD

Anneriet Dassen

Daniëlle de Leeuw

Anneriet Dassen, PhD

The sentinel lymph nodes (SLNs) are the first lymph nodes (LNs) to drain the tumor site and therefore the first LNs to bare metastases. Hence the importance to investigate these LNs for the best treatment strategy. Current-standard-of-care for melanoma patients with a melanoma stage of pT1b or higher, involve a surgical procedure, referred to as SLN biopsy (SLNB). The SLNB procedure involves a combined detection procedure using a radio-active tracer and blue dye followed by surgical dissection and evaluation of the LNs at the histopathology department. Due to the use of radioisotopes, this procedure suffers from several disadvantages such as limited availability, strict rules and regulations, degradation time in patient and radioactive load for user and patient.

To overcome the limitations of a radioactive tracer, a magnetic SLNB was developed which is facilitated by super paramagnetic iron-oxide (SPIO) nanoparticles. This potentially offers numerous benefits making surgery planning more flexible: no exposure to radiation, easy accessibility of the tracer, long shelf life and long half time in the patient. However, the currently available magnetometer for intraoperative detection of SPIO-enhanced LNs is hampered by a relatively low detection depth, biological noise, and effects of surgical equipment. Therefore, surgeons need to switch to plastic or carbon equipment and the system needs to be balanced prior to each measurement, which increases the surgery time.

A new and effective way to localize SPIOs is differential magnetometry (DiffMag). This patented detection principle, developed by MD\&I group at University of Twente (UT), utilizes the nonlinear magnetic response of nanoparticles. An additional advantage of SPIOs is their visibility on MRI, which could provide mapping the SLNs preoperatively. Especially in patients with melanomas on the abdomen or back this would be very useful to see which lymph node stations are connected to the melanoma. In addition, studies have shown that SPIOs are absorbed into lymph nodes in different ways, depending on the presence of metastases. SPIO-enhanced MR lymphography could therefore provide an opportunity for a non-invasive preoperative assessment of nodal status.

In this pilot study the investigators want to evaluate the clinical use of the DiffMag handheld probe. Moreover, the investigators want to map the lymph nodes (metastases) preoperatively using MR lymphography.

MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients

MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients Measured With DiffMag

Determining the feasibility of SLN detection/localization in melanoma patients using a magnetic tracer (Magtrace®) and hand-held magnetometer DiffMag.

Determining the feasibility of SLN detection/localization in melanoma patients using a magnetic tracer (Magtrace®) and hand-held magnetometer Sentimag.

Determining the feasibility of LN mapping with preoperative SPIO-enhanced MR lymphography and examining the use of SPIO-enhanced MR lymphography for LN staging.

University of Twente

PhD student / coordinating investigator

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Intraoperative sentinel lymph node identification (lymphatic mapping)

Intraoperative hysteroscopic injection of patent blue dye and radiocolloid for detection of sentinel lymph nodes.

Intraoperative Lymphatic Mapping

Michael M. Frumovitz, MD

The goal of this clinical research study is to learn if a procedure called intraoperative (during surgery) lymphatic mapping can be used to find the sentinel lymph node in patients with endometrial cancer.

Experimental Procedures:

Lymph nodes are oval-shaped glands where immune reactions occur. For patients with endometrial cancer, lymph node status is an important factor for planning the cancer treatment course and predicting the status of the cancer. The "sentinel" node is the lymph node closest to the main tumor area, and it is believed to be at greatest risk for spread of the cancer. If the sentinel node does not contain cancer cells, then the remaining lymph nodes are usually cancer-free.

In this study, researchers want to study possibly using lymphatic mapping in future patients as an alternative to completely removing the lymph nodes in the pelvis (hip area) and para-aortic (upper abdomen) area.

Intraoperative sentinel lymph node identification (lymphatic mapping) uses 2 techniques. The first technique involves injecting a small amount of weak radioactive material, and the second involves injecting a drug called isosulfan blue or methylene blue. These techniques are being studied to see if the surgeon can locate ("map") lymph nodes that may contain tumor cells.

Routine Surgical Treatment:

As part of routine care, all participants in this study will have surgery to remove the uterus, cervix, 1-2 inches of the vagina, fallopian tubes, ovaries, and the lymph nodes in 2 areas of the waist.

Study Procedures:

If you agree to take part in this study, after you have been given the anesthetic for your surgery, your uterus will be examined to locate the tumor(s). After the tumor(s) are located, they will be injected with a radioactive substance called Tc-99m sulfur colloid. The tumors will then be injected with a dye called isosulfan blue or methylene blue, which is used to turn the sentinel node blue.

Before and during your surgery, a gamma counter (a special hand-held instrument that measures radioactivity) will be used to identify lymph nodes that have absorbed the Tc-99m sulfur colloid. The surgeon will also be able to see the lymph nodes that have absorbed the blue dye.

Information Collection:

In addition to the study procedures, researchers will collect clinical information about you that will be compared with the study results. This information includes your date of birth, age, race, height, weight, number of any past pregnancies and deliveries, any other medical conditions, and any earlier surgeries. It also includes the date of the cancer diagnosis, the status of the cancer diagnosis before surgery, the status of the disease, and the results of routine scans before surgery (chest x-ray and computed tomography \[CT\] or magnetic resonance imaging \[MRI\] scan, if performed).

Length of Study Participation:

Your participation in this study will be over after the 15-20 minute procedure for identifying the sentinel nodes. The routine surgery will occur after that, which can take up to 5 hours.

This is an investigational study. Tc-99m sulfur colloid, the blue dye (either isosulfan blue or methylene blue), and the gamma counter are FDA approved for the procedures used in this study.

Performing lymph node mapping and sentinel node identification during surgery in patients with endometrial cancer is considered experimental.

Up to 20 women will take part in this multicenter study. Up to 10 will be enrolled at M. D. Anderson.

Hysteroscopic Lymphatic Mapping for Endometrial Cancer

Hysteroscopic Injection of Tracers for Sentinel Node Identification in Women With Endometrial Cancer

Feasibility of sentinel node identification rate using intraoperative hysteroscopic injection of patent blue dye and radiocolloid for the detection of sentinel lymph nodes in patients with endometrial cancer. Sentinel node identification before and during surgery using a gamma counter to identify lymph nodes that have absorbed Tc-99m sulfur colloid. Study feasibility assessed with enrollment of 20 participants, approximately 1 year.

M.D. Anderson Cancer Center

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Early termination due to low detection rate of sentinel lymph nodes in the five participants.

Dr. Michael Frumovitz, ND/Assistant Professor

Analysis was per protocol; no analysis conducted due to low detection rate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer	NCT04053101	Muscle Invasive...	PET CT	18 Years -	Institut Bergonié
MR Lymphography and Magnetic Sentinel Lymph Node Biopsy in Melanoma Patients	NCT05569707	Melanoma (Skin)	Magnetic sentin...	18 Years -	University of Twente
Hysteroscopic Lymphatic Mapping for Endometrial Cancer	NCT00671606	Endometrial Can...	Intraoperative ...	-	M.D. Anderson Cancer Center
Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer	NCT04053101	Muscle Invasive...	PET CT	18 Years -	Institut Bergonié
Role of FDG-PET CT in the Management of Muscle Invasive Bladder Cancer	NCT04053101	Muscle Invasive...	PET CT	18 Years -	Institut Bergonié
Hysteroscopic Lymphatic Mapping for Endometrial Cancer	NCT00671606	Endometrial Can...	Intraoperative ...	-	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for lymph node staging