Neoplasms

Gland and Hormone Related Diseases

All Conditions

Thyroid Neoplasms

Thyroid Diseases

Adenoma

Endocrine System Diseases

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Micronutrients

Anti-Infective Agents

All Drugs and Chemicals

Iodine

Cadexomer iodine

Ana K Sodré

Rosalinda Y Camargo

The uptake of iodide by thyroid cells requires the expression of sodium iodide symporter (NIS). Thyroid benign and malignant tumors have low iodide uptake activity. Previous studies of NIS expression with RT-PCR and immunohistochemistry showed divergent data. NIS protein was overexpressed in thyroid cancer. The aim of this study was to investigate the NIS transcript levels and its presence and localization in 30 samples of thyroid tumors (14 benign and 16 malignant) and in their surrounding non-tumoral tissues (NT), by real time RT-PCR and immunohistochemistry, respectively. Our results revealed lower gene expression in 78.6% of the benign tumors and 100% of the carcinomas when compared with the NT samples, using GHPDH as a housekeeping gene. Immunohistochemical staining revealed presence of NIS protein in 100% of the non-tumoral samples, 100% of the benign tumors and 93.75% of the malignant tumors. NIS protein was identified at basolateral membrane in 23.3% of non-tumoral samples, 14.3% of benign and 12.5% of malignant tumors. Stronger cytoplasmatic immunostaining of NIS protein was detected in 64.3% of benign tumors and in 87.5% of malignant tumors when compared to NT. Association between low gene expression and strong cytoplasmatic immunostaining was found in 50% of benign tumors and 87.5% of malignant tumors. We concluded that the reduced NIS gene expression in thyroid tumors associated with strong intracytoplasmatic staining may be due to its incapacity to migrate to cellular membrane.

The aim of this study was to quantify NIS transcript levels by real time PCR and to determine the presence and cellular localization of NIS protein by immunohistochemistry, in benign and malignant thyroid tumor cells and to compare with their paired surrounding non-tumoral cell. NIS expression was also compared to that of the TSHR

Expression of NIS Protein and mRNA in Thyroid Tumors

Significant Intracellular NIS Protein Associated With Low Levels of NIS Messenger RNA in Malignant Thyroid Tumors

Fundação de Amparo à Pesquisa do Estado de São Paulo

University of Sao Paulo

Thyroid Nodule

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Central Nervous System Depressants

Anesthetics

Patients who will undergo thyroidectomy will be evaluated by an ENT physician by flexible fiberoptic laryngoscopy before the surgery

The same patients evaluated by flexible fiberoptic laryngoscopy will be evaluated by an anesthesiologist by direct laryngoscopy during surgery under general anesthesia

Patients who will undergo thyroidectomy will be evaluated by awake flexible fiberoptic laryngoscopy and during surgery by direct laryngoscopy under general anesthesia

Flexible fiberoptic laryngoscopy

Patients who will undergo thyroidectomy evaluated before by ENT physician, will be evaluated by anesthesiologist in means of MCL score by direct laryngoscopy during surgery under general anesthesia

Direct laryngoscopy

Cigdem Akyol Beyoglu, MD

Emine D Gozen, MD

Emine D Gozen

Guniz Koksal, Prof

Nowadays, 5-step modified Cormack-Lehane scoring (MCL) system is frequently used in the observation of laryngeal structures by direct laryngoscopy.

Upper airways with flexible fiberoptic laryngoscopy are routinely evaluated in patients who are predicted to be difficult intubation, who have undergone head or neck surgery previously and who require vocal cords to be evaluated preoperatively. During this examination patients are awake; so the upper airway and the muscles in the base of the mouth have normal tonus and airway reflexes are active. When general anesthesia is applied to the same patients during direct laryngoscopy, the laryngeal view may not be as clear as awake flexible fiberoptic laryngoscopy, since a tonus loss occurs in the muscles after general anesthesia.

The aim of the study is to investigate the relationship between preoperative awake flexible fiberoptic laryngoscopy performed by ear- nose- throat (ENT) physicians in patients undergoing total thyroidectomy, and the MCL score during direct laryngoscopy after general anesthesia in the same patients. Thus, investigators would like to determine the reliability of airway evaluation with preoperative awake flexible fiberoptic laryngoscopy in predicting intubation conditions during tracheal intubation under general anesthesia.

In daily practice, the upper airway evaluation is performed by the ENT physician with flexible fiberoptic laryngoscopy while the patients are awake one day before thyroidectomy. This evaluation will be done by the same ENT physician (EDG). Each patient will be kept in the neutral position and at the level of soft palate, the larynx will be observed by the flexible fiberoptic laryngoscopy and the laryngeal view and MCL score of these patients will be recorded.

The same patients will be taken to the preoperative care unit on the morning of operation and 20 G intravenous cannulation will be performed on the left hand. Patients' neck circumference and Mallampati score and presence of obstructive sleep apnea syndrome will be recorded. Patients will be taken to the operation theatre and standard monitoring will be performed consisting of electrocardiography (ECG), non-invasive blood pressure (BP) and peripheral O2 saturation. After induction of general anesthesia, the same anesthesiologist (CAB) will perform direct laryngoscopy by using Macintosh laryngoscope the MCL score will be recorded. The anesthesiologist will not know the MCL score that was previously evaluated by ENT physician during awake fiberoptic flexible laryngoscopy. Female and male patients will be intubated orotracheally with 7.5-8 internal diameter endotracheal tube, respectively. It will be recorded if the backward, upward, right, lateral pressure Maneuver (BURP) is applied during intubation. The maintenance of general anesthesia will be provided with 2% Sevoflurane in a 40% oxygen-air mixture.

After thyroidectomy is over patients will be extubated. The primary endpoint of the study was to evaluate the relationship between the MCL score, which was evaluated preoperatively, and the MCL score during direct laryngoscopy during intraoperative general anesthesia in awake patients.

Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia

The Relationship of Modified Cormack Lehane Scores Between Preoperative Awake Flexible Fiberoptic Laryngoscopy and Intraoperative Direct Laryngoscopy in Thyroidectomies, a Prospective, Clinical Study

all collected individual participant data (IPD)

The primary outcome measure of the study is a 5 graded modified Cormack Lehane scores obtained from patients before and during thyroidectomy. The first measurement will be done one day before surgery, while patient is awake by flexible fiberoptic laryngoscopy. The second measurement will be done during surgery, after induction of general anesthesia by direct laryngoscopy

Istanbul University

Medical doctor

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Skin and Connective Tissue Diseases

Nutritional and Metabolic Diseases

Nervous System Diseases

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Colonic Neoplasms

Breast Neoplasms

Lung Diseases

Sarcoma

Protein-Energy Malnutrition

Thyroid Cancer, Papillary

Respiratory Tract Diseases

Central Nervous System Neoplasms

Thoracic Neoplasms

Fibrosarcoma

Respiratory Tract Neoplasms

Bronchial Neoplasms

Carcinoma, Bronchogenic

Nervous System Neoplasms

Myofibromatosis

Neoplasms, Connective and Soft Tissue

Adenocarcinoma

Adenocarcinoma, Papillary

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Soft Tissue Sarcoma

Papillary Thyroid Carcinoma

Thyroid Cancer, Medullary

Infantile Myofibromatosis

Herbal and Botanical

Cola

Phase 1- Dose Escalation and determination of MTD; multiple dose levels of LOXO-292 to be evaluated; Phase 2 - The MTD/recommended dose from Phase 1

LOXO-292

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Leo Mascarenhas

Margaret Macy

Ramamoorthy Nagasubramanian

Steven DuBois

Emily Greengard

Julia Glade Bender

Brian Turpin

Frank Balis

Alberto Pappo

Tanya Watt

Stephanie Fetzko

Douglas Hawkins

David Ziegler

Martin Campbell

Daniel Alexander Morgenstern

Karstend Nysom

Charlotte Rigaud

Cornelis Van Tilburg

Michela Casanova

Atushi Manabe

Ayumu Arakawa

Shuhei Karakawa

Katsutsugu Umeda

HyoungJin Kang

Raquel Hladun

Sara Stoneham

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.

This study includes 2 parts: phase 1 (dose escalation) and phase 2 (dose expansion). In phase 1, participants will be enrolled using a rolling 6 dose escalation scheme. The starting dose of LOXO-292 is equivalent to the adult recommended phase 2 dose of 160 milligrams (mg) twice a day (BID). Once the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) is identified, participants will be enrolled to one of four phase 2 dose expansion cohorts depending on tumor histology and tumor genotype. Cycle length will be 28 days.

A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors

A Phase 1/2 Study of the Oral RET Inhibitor LOXO 292 in Pediatric Patients With Advanced RET-Altered Solid or Primary Central Nervous System Tumors

Tumor stage is described according to the Tumor, Node, Metastasis (TNM)Classification of malignant tumors of the Union for International Cancer Control (UICC)

Tumor margins after surgery are classified into four groups using the International Cancer Control (UICC)-R classification and the Intergroup Rhabdomyosarcoma Staging (IRS) systems: 1) Complete tumor resection with histologically free margins, 2) Macroscopic resection but invaded margins on histology, 3)Macroscopic residual tumor and 4) Distant metastatic tumor.

Eli Lilly and Company

Loxo Oncology, Inc.

Thyroiditis

Glenn D. Braunstein, M.D.

Anja Kammesheidt, PhD

When the DNA inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. The cancer cells may shed this DNA into the blood stream. This circulating tumor DNA (ctDNA) can be detected by very sensitive, specialized laboratory tests. Measurement of ctDNA has been shown to be useful for following patients with known cancer. The purpose of this study is to examine blood specimens for the presence of ctDNA in individuals without known cancer who are scheduled to undergo a fine needle aspiration biopsy of the thyroid gland because of one or more thyroid nodules in order to see if the ctDNA test can detect a cancer at a very early stage. The results of this study should help define the role of ctDNA in the detection of early stage thyroid cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctDNA found in patients with benign thyroid nodules).

After the participants with thyroid nodules or other abnormalities have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. This will be done prior to the performance of the fine needle aspiration biopsy of the thyroid. If the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their physician. The patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of thyroid or other cancer.

Blood is drawn and DNA is purified from the plasma. The DNA is analyzed for circulating tumor DNA. The DNA will be stored for up to 10 years with the patient's permission.

ctDNA in Patients With Thyroid Nodules

Determination of the Utility of Plasma Circulating Tumor DNA (ctDNA) Measurements for Detection of Thyroid Cancer in Patients Undergoing Diagnostic Fine Needle Aspirations of the Thyroid

The patient's physician will receive the results and the patients have the option to also receive the results.

Correlation between plasma ctDNA results with pathology from the diagnostic fine needle aspiration biopsy of the thyroid gland.

Determination of true positive, false positive and predictive values for using ctDNA measurements to detect thyroid cancer.

Subjects will be contacted yearly to obtain follow-up information regarding the development of thyroid or other cancer in order to see if the initial ctDNA measurement detected the cancer before it became clinically apparent.

Pathway Genomics

Eye Diseases

Immune System Diseases

Graves Disease

Goiter

Exophthalmos

Orbital Diseases

Hyperthyroidism

Autoimmune Diseases

Patients set for total thyroidectomy incl. functional total thyroidectomies.

Both 2D and 3D ultrasound is being used. 3D using optical tracking.

BK 5000 Ultrasound Machine

Klara Bay Rask

Tobias Todsen, MD, PhD, Associate Professor

Tobias Todsen, MD, PhD, associate professor

The purpose of this clinical trial is to investigate the accuracy of applying three-dimensional ultrasound on thyroid gland patients when determining a gland volume.

The method will be compared to conventional b-mode ultrasound where three axis measurements (length, width, and depth) are evaluated in the ellipsoid model.

The three dimensional (3D) method is utilizing optical tracking connected to the ultrasound image to form cross-sectional imaging. Patients enrolled in the study are set for complete thyroidectomies enabling a true volume of the gland by water displacement after excision.

The aim is to find if this 3D method is more accurate in volume estimation than the ellipsoid model.

Three-dimensional Ultrasonography Thyroid Volume Measurement.

Three-dimensional Ultrasonography: Accuracy in Thyroid Volume Measurement.

Obtaining thyroid volume with 2D ultrasound (length x Width x depth\*(Pi/6)) and 3D ultrasound with optical tracking and comparing the respective methods with a reference volume. Water displacement being gold standard for reference volume.

Looking af the change in volume invivo vs exvivo w. 2D and 3D ultrasound

Variation in volume estimation when delineating ultrasound images.

Rigshospitalet, Denmark

Stud.Med.

Parathyroid Neoplasms

Parathyroid Diseases

Parathyroid Hormone

patients admitted for Tc MDP for evaluation of carpal/metacarpal and finger bone lesions

patients investigated for parathyroid adenoma

patients who are due to sentinel node biopsy

Einat Even Sapir, PhD,MD

Ayelet Kurzband, BA

Einat Even Sapir, PhD, MD

Hedva Lerman, MD

Einat Even-Sapir, MD, PhD

The purpose of the study is to check if the new CZT system has an advantage in detection of small osseous processes, thyroid adenomas, parathyroid adenomas and detection of sentinel node, in comparison with the techniques in use.

Participants: 100 subjects male and female that come to the institute of nuclear medicine for routine screening examinations.

The CZT screening takes 10 minutes and does not require any extra intervention to the routine screening.

Evaluation of a New CZT System

Evaluation of a New CZT System for Imaging in Routine Nuclear Medicine Examination

Tel-Aviv Sourasky Medical Center

Einat Even-Sapir MD, PhD. Head, Dept of Nuclear Medicine

Norman Eberhardt, PhD

This protocol will evaluate microRNA biomarkers in blood and fine-needle aspirate biopsies (FNAB) of thyroid nodules. MicroRNA profiles will be determined and evaluated for their utility in pre-operative diagnosis, in particular to distinguish benign from malignant throid neoplasms. Post-surgical fresh-frozen thyroid cancer tissue will be assessed for somatic mutations, mRNA, and microRNA expression patterns. FFPE tissue will be used to obtain H\&E and unstained slides to specific biomarker results using immunohistochemistry.

This protocol requires the collection of blood (5 ml), fine-needle aspirate biopsies (FNAB), and post-surgical thyroid cancer tissue. The post surgical tissue includes fresh-frozen tissue that is considered waste and in excess of that required for pathologic diagnosis, and archived formalin-fixed, paraffin-embedded tissue (FFPE). The blood will be used as a substrate for assessing known markers, including microRNA expression patterns that may be useful to predict disease and thyroid cancer morphotype. The FNABs will be used to screen the potential of markers for pre-operative diagnosis. The post-surgical fresh-frozen thyroid cancer tissue will be used to isolate DNA and RNA in order to assess somatic mutations (RAS and PAX8/PPAR-gamma rearrangement) and messenger RNA, and microRNA expression patterns. The FFPE tissue will be used to obtain H\&E and unstained slides to validate results using immunohistochemistry. The goal of these studies is to define molecular markers that will accurately distinguish benign from malignant disease and the multiple thyroid cancer phenotypes. Current methods of distinguishing benign from malignant disease requires a detailed post-surgical analysis and no known markers have yet been identified to reliably differentiate the multiple thyroid cancer morphotypes.

Blood, RNA/DNA from fine needle aspirate biopsies of thyroid nodules, fresh frozen surgical tissue, formalin fixed paraffin embedded tissue.

Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm

Biomarkers in Thyroid Cancer

Biomarkers will be identified to distinguish benign follicular adenoma from follicular carcinoma of the thyroid.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Expression of NIS Protein and mRNA in Thyroid Tumors	NCT00459498	Tumors		18 Years - 80 Years	University of Sao Paulo
Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia	NCT03826680	Thyroid Cancer Thyroid Nodule Thyroid Adenoma	Flexible fibero... Direct laryngos...	18 Years - 70 Years	Istanbul University
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
ctDNA in Patients With Thyroid Nodules	NCT02778412	Thyroid Cancer Thyroid Nodules Thyroid Adenoma Thyroiditis		18 Years -	Pathway Genomics
Three-dimensional Ultrasonography Thyroid Volume Measurement.	NCT05510609	Thyroid Thyroid Cancer Thyroid Disease... Graves Disease Thyroid Goiter Thyroid Adenoma	BK 5000 Ultraso...	18 Years - 110 Years	Rigshospitalet, Denmark
Evaluation of a New CZT System	NCT01084356	Parathyroid Ade... Thyroid Adenoma		18 Years -	Tel-Aviv Sourasky Medical Center
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors	NCT03899792	Medullary Thyro... Infantile Myofi... Infantile Fibro... Papillary Thyro... Soft Tissue Sar...	LOXO-292	6 Months - 21 Years	Eli Lilly and Company
Modified Cormack Lehane Scores Evaluated by Laryngoscopy During Awake Versus Under General Anesthesia	NCT03826680	Thyroid Cancer Thyroid Nodule Thyroid Adenoma	Flexible fibero... Direct laryngos...	18 Years - 70 Years	Istanbul University
Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm	NCT01433809	Cancer of the T... Neoplasms, Thyr... Thyroid Adenoma Thyroid Cancer Thyroid Carcino...		18 Years - 90 Years	Mayo Clinic

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