Neoplasms

All Conditions

Head and Neck Neoplasms

Single session of 4 intratumoral injections consisting of 0.1-0.3 ml radioactive Holmium-166 microsphere suspension with a total activity 30 Megabecquerel, 7-12 days prior to surgical resection.

Intratumoral injections of Holmium-166 (poly L lactic acid) microspheres

Holmium-166 (poly L lactic acid) microspheres

Marnix G Lam, MD, PhD

The main objective is to establish the feasibility of 166-Holmium microspheres for intratumoral injections in oral squamous cell carcinoma (OSCC) of the tongue.

Participants will receive intratumoral injections with a low radioactive 166-Holmium microspheres followed by surgical resection

166-Holmium microspheres poly lactic acid microspheres are currently used in selective internal radiation therapy. These microspheres emits beta radiation. The majority of the radiation dose will be absorbed within 3.2 mm with a maximum penetration in tissue of 9 mm. Therefore this can result in a high local tumor ablative dose with minimal dose to healthy adjacent tissue.

Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors

Feasibility of Holmium-166 Microspheres for Selective Intra-tumoural Treatment in Head and Neck Cancer: Biodistribution and Safety in Patients With Malignancy of the Tongue

SPECT Thorax and Abdomen Radioactivity in a blood and urine sample

UMC Utrecht

Professor Nuclear medicine

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Tongue Cancer

Antineoplastic Agents

All Drugs and Chemicals

Cetuximab

Antineoplastic Agents, Immunological

Drug administration ,Cetuximab(merck Serono )given neoadjuvant ,3 courses prior surgery followed by post operatve radiation and Cetuximab

cetuximab loading dosage 400mg/m2 followed by weekly 250mg/m2 2 weeks

Erbitux,merck serono

Aron Popovtzer, MD

Dror Limon, MD

Salomon Stemmer, MD

Rafael Feinmesser, MD

Thomas Spitzer, MD

Gideon Bachar, MD

To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501 and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease.

This non-randomized, open-label, single center phase II study, will determine if patients with advanced oral tongue cancer that are treated with induction doses of cetuximab followed by treatment with radiation therapy concurrently with cetuximab and cisplatin (when indicated by positive margins or extra-capsular extension), will have improved PFS and improved survival and feasible toxicity, compared with patients treated in previous clinical trials (RTOG 9501 and EORTC 22931) with standard therapy: radiotherapy of 60 Gy with or without a 6-Gy boost (RTOG 9501) or 66 Gy (EORTC 22931) delivered through a conventional fractionation regimen of five once-daily sessions per week, and cisplatin in a dose of 100 mg/m2 on days 1, 22, and 43.. Twenty five patients will be recruited. Cetuximab treatment will be started (day 0) with 400 mg/m2 followed by two doses of 250 mg/m2 (once weekly on day 7 and 14). Surgery will be performed on day 31 followed by treatment with radiation therapy concurrently with cetuximab (250 mg/m2, once weekly) and cisplatin 35 mg/m2 (days 70-112; when indicated by positive margins or lymph nodes with extra-capsular extension). PET-CT and biopsies will be performed before starting with cetuximab, just before surgery and after chemo-cetuximab-RT to determine efficacy of treatment, and to compare the diagnostic properties of the PET-CT with that of the biopsies. The changes, before and after treatment with cetuximab, of protein levels in saliva, and tumor tissue and of microRNA levels in tumor tissue will be studied and correlated with PFS. The quality of life will be assessed. Data from clinical trials RTOG 9501 and EORTC 22931 will be used as historical controls.

CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT

CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment Followed by 6 Weeks of Cetuximab+RT Post Surgery in Locally Advanced Squamous Cell Carcinoma of the Tongue ; A NEW PARADIGM OF TREATMENT

To evaluate the role of downregulation of microRNAs according to the outcome of treatment

: To compare the Disease free survival (DFS) rate of a preoperative cetuximab treatment followed by operation and postoperative radiation-cisplatin-cetuximab treatment paradigm for advanced oral cavity cancer, , with the DFS rate of historical controls (from the RTOG 9501 and EORTC 22931 studies in which treatment was with surgery followed by radiotherapy and cisplatin) with a similar stage of the disease

To evaluate the frequency and severity of adverse events (AEs) for this treatment paradigm.

To evaluate the correlation between changes in expression levels of several biomarkers related to cell apoptosis and tumor progression: the endothelial growth factor receptor pathway, p53, human papilloma virus, BCL-2, BCL-X(L), and acid ceramidase - before and after treatment - with survival rates, PFS and response rates

Kaplan Medical Center

Meir Medical Center

Rabin Medical Center

Head of head and neck cancer unit

Mouth and Tooth Diseases

Tongue Neoplasms

In squamous cell carcinoma of the tongue, complete surgical resection of the tumor

tongue surgery

Christophe ATTENCOURT, MD

In squamous cell carcinoma of the tongue, complete surgical resection of the tumor generally represents the primary treatment strategy. Among factors determining the disease prognostic, the surgical margins status is essential for the continued management of the patient, with or without complementary therapies. Generally, surgical margins are defined using visual and tactile elements. Unfortunately, in 15 to 30 percent of cases, they are defined as positive after histopathological examination, on average 5 to 7 days post-surgery.

Techniques have recently been developed to analyze the cancerous and non-cancerous nature of tissues, using the spectral properties of tumor cells. SpiderMass™ is an instrument equipped with a probe for tissue micro-sampling and real-time molecular profile analysis. It is thus ultimately a tool for anatomopathological decision support, for diagnosis and prognosis of the disease. Used in the operating room, SpiderMass™ could also become an innovative surgical tool to precisely define cancerous areas in situ and the margins status in intraoperative conditions.

Based on the principle of artificial intelligence, the SpiderMass™ machine must initially learn to recognize pathological tissues versus healthy. This project aims to accomplish this first phase of machine learning for squamous cell carcinoma of the tongue.

Tissue samples will be taken from the tumor and the non-tumor areas. Surgical specimens will be taken in a fresh state immediately after surgery, by an anatomopathologist and a pathological anatomy technician. The sample will be analyzed under standard conditions. Two sites will be selected macroscopically (including a tumor area, a dysplasia area, and a non-tumor area).

Spectroscopic Analysis of Tongue Tumor Samples.

Prospective Analysis of Tumor Tissues From the Oral Cavity by SpiderMassTM Spectroscopy

Tumor cells detection in tongue tumor with SpiderMass technique

Université de Lille

Centre Hospitalier Universitaire, Amiens

Digestive System Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Xiuli Zuo, MD, PhD

Xiuli Zuo, MD,PhD

This study combines artificial intelligence with tongue images, by collating and collecting tongue images and diagnostic and pathological results of gastroscopic diseases, mining and analysing the correlation between tongue images and OLGA, OLGIM stages, Correa sequences and constructing prediction models, to deeply investigate the relationship between tongue images and precancerous diseases, precancerous lesions and gastric cancer.

Firstly, tongue pictures and patient information will be collected after the patient signed an informed consent form.

Secondly, after the patient undergoes gastroscopy, patient gastroscopy reports and pathology reports will be obtained.

Thirdly, the investigator will assess the patient's gastroscopy report for the Correa sequence of gastric cancer with OLGA and OLGIM staging.

Finally, the patient's tongue image, information and gastric cancer cascade response are matched to construct an artificial intelligence model and assess the quality of the model.

Combining Tongue and Gastric Cancer Cascade With Artificial Intelligence

Analyzing the Link Between Tongue Images and Gastric Cancer Cascade Response Using Artificial Intelligence Techniques

Sensitivity of artificial intelligence models Sensitivity = number of true positives / (number of true positives + number of false negatives) \* 100%.

Specificity of Artificial Intelligence Models Specificity = number of true negatives / (number of true negatives + number of false positives))\*100%

Positive predictive values from artificial intelligence models Positive predictive value = true positive / (true positive + false positive)\*100%

Negative predictive values for artificial intelligence models Negative predictive value = true negative / (true negative + false negative)\*100%

area under the receiver operating characteristic curve (AUC)

Accuracy of artificial intelligence models Accuracy = (true positives + true negatives) / total number of subjects \* 100%

Shandong University

doctoral supervisor of Qilu Hospital gastroenterology department

Mouth Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Anti-Infective Agents

Flavonoid

Doxorubicin

Liposomal doxorubicin

Quercetin

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Antioxidants

Protective Agents

Appearance (Color) Conforms Yellow Appearance (Form) Powder

1H NMR Spectrum Conforms to Structure Loss on Drying \< 4 % _ Purity (HPLC) \> 95 %

Quercetin 3,3',4',5,6-Pentahydroxyflavone, 2-(3,4-Dihydroxyphenyl)-3,5,7-trihydroxy-4H-1-benzopyran-4-one

Nano QUT will prepared by PLGA-PEG nanocomposites that will be prepared by an oil-in-water (O/W) single emulsion solvent evaporation method

Quercetin-encapsulated PLGA-PEG nanoparticles (Nano-QUT)

Doxorubicin is a type of chemotherapy drug called an anthracycline. It slows or stops the growth of cancer cells by blocking an enzyme called topo isomerase 2

Doxorubicin chemotherapeutic drug as a positive control

Hana'a Algadi, P.h.D

Squamous cell carcinoma (SCC) is the most common oral cavity carcinoma. Conventional therapeutic modalities for oral malignancy include surgery, radiotherapy and chemotherapy alone or in combinations.The major obstacle of using current anticancer drugs is; first the non-specific tissue distribution, as these drugs are unable to distinguish between normal and cancer cells.Quercetin is a bioactive flavonoid having strong antioxidant properties. .Among all the nanomaterials, polymeric nanoparticles are of significant interest for drug delivery applications due to many unique features of nanoparticle polymers.This is the first study to investigate the anticancer effects of (Quercetin) either free or encapsulated by PLGA-PEG NPs in tongue squamous cell carcinoma (TSCC) cell line.

Squamous cell carcinoma (SCC) is the most common oral cavity carcinoma. Conventional therapeutic modalities for oral malignancy include surgery, radiotherapy and chemotherapy alone or in combinations. The major obstacle of using current anticancer drugs is; first the non-specific tissue distribution, as these drugs are unable to distinguish between normal and cancer cells. Quercetin is a bioactive flavonoid having strong antioxidant properties. It is naturally present in a wide variety of fruits and vegetables. Among all the nanomaterials, polymeric nanoparticles are of significant interest for drug delivery applications due to many unique features of nanoparticle polymers. Polymeric nanocarriers have been fabricated from natural and synthetic polymers. Poly ethylene glycol-poly lactide-co-glycolic acid (PEG-PLGA) amphiphilic copolymer is an emergent system because it can be easily synthesized and possesses a lot of good qualities. Several previous in vitro and in vivo studies have evaluated the cytotoxic effects of quercetin and have revealed that it decreases cell viability and increases cell apoptotic rate in OSCC. However, the anti-cancer property of quercetin in tongue squamous cell carcinoma (TSCC) has not been studied yet. This is the first study to investigate the anticancer effects of (Quercetin) either free or encapsulated by PLGA-PEG NPs in tongue squamous cell carcinoma (TSCC) cell line.

Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line

MTT assay for cellular viability:

The cytotoxic impacts of the tested drugs and Nano QUT-encapsulation will be measured by MTT. The (HNO-97) cells will be cultured in 96-well plates at a density of 5 × 103 cells/well. All drugs with their described concentrations will be added to the media over tongue SCC cell lines. After a day of incubation, the dissolved MTT in PBS will be added to each well at a final concentration of 5 mg/ml, and the samples will be incubated at 37 °C for 4h. Water-insoluble dark blue formazan crystals that will be formed during MTT cleavage in actively metabolizing cells will then be dissolved in dimethyl sulfoxide (DMSO). Absorbance will be measured at A455 nm, using an ELISA microplate reader

Annexin V and propidium iodide (PI) stains will be used in the determination of apoptosis after treatment with the free, nano counterpart of QUT and free Dox post 24h of their incubation over the HNO-97 cell line. The apoptotic analysis will be dedicated to differentiating between early and late apoptotic cells, as well as necrotic cells. The apoptosis of the treated and untreated HNO-97 line with the proposed free, nano counterpart of Nano-QUT and Dox will be analyzed by ﬂow cytometer apparatus

Following treatment with the proposed free DOX, free and Nano-QUT formulations for 24 h, the cells are harvested, lysed and tested with RT-PCR using specific primers to estimate the fold change of the apoptotic signals (BCL-2 and Bax) and survival pathway (Expression of PI3K gene). GAPDH will be used as a housekeeping gene to normalize the level of target gene expression.

Following treatment with the proposed free DOX, free and Nano-QUT formulations for 24 h, the cells are harvested, lysed and tested with RT-PCR using specific primers to estimate the fold change of the apoptotic Bax gene

Following treatment with the proposed free DOX, free and Nano-QUT formulations for 24 h, the cells are harvested, lysed and tested with RT-PCR using specific primers to estimate the fold change of survival pathway (Expression of pi3k gene)

Cairo University

Ph.D. candidate at Oral &Maxillofacial Pathology Department- Faculty of Dentistry

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Penile Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Penile Diseases

Male Urogenital Diseases

Penile Cancer

Baris Karakullukcu, MD, PhD

In this study we evaluate the feasibility of intraoperative visualization of penile and tongue tumours using the fluorescent tracer EMI-137.

This is a single-center, non-randomized, prospective interventional pilot study. Feasibility of intraoperatively visualizing tumour (margins) in penile and tongue tumours using EMI-137 will be investigated. Patients, ≥ 18 years of age, with ≥T1 penile or tongue cancer undergoing primary tumour surgery will be included. All patients will receive an intravenous bolus injection of EMI-137 prior to surgery. Main study parameters/endpoints are: Intraoperative visualization of primary penile or tongue tumours using a dedicated clinical fluorescence camera. The in vivo detected fluorescence signal will be correlated to ex vivo measurements and pathological assessment of the ex-cised tissue.

INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue

The feasibility of intraoperative tumour visualization by means of c-MET targeted fluores-cence imaging will be evaluated, and the imaging result will be correlated to the level of c-MET expression determined using standard immunohistochemistry.

Detection and visualization of lymph node metastases in penile and tongue tumour patients

Identification of dysplasia or carcinoma in situ in penile and tongue tumours.

The Netherlands Cancer Institute

Squamous Cell Carcinoma of Head and Neck

Oral Squamous Cell Carcinoma

Pharmaceutical Solutions

Olaparib

Poly(ADP-ribose) Polymerase Inhibitors

In the phase I of the study, increasing concentrations of PARPi-FL will be used in up to 12 patients with OSCC to determine concentration that results in the highest contrast between tumor and normal mucosa. Dose escalation will be performed in groups of three patients until image contrast decreases, side effects are noted or the concentration of PARPi-FL exceeds 1μM. Imaging will be performed in the Department of Surgery during a presurgical visit including clinical examination of the oral cavity. In the phase II part of the study the concentration of PARPi-FL determined in phase I will be used to image 18 patients with OSCC on the day of surgery. Imaging findings will be correlated with histopathologic findings in the surgically resected specimens.

For PARRi-FL, imaging patients will first gargle a solution of PARRi-FL for 1 min, then spit out this solution and gargle with a cleaning solution (the solvent used for PARRi-FL) for 1 min. Then fluorescence imaging of the oral cavity and pharynx will be performed with an endoscope. The intensity and extent of the fluorescence signal will be recorded by one of the investigators for the tumor and adjacent normal mucosa.

Heiko Schoder, MD

Ravinder Greawl, MD

Ravinder Grewal, MD

The purpose of this study is to test if an investigational dye, called PARPi-FL, can be used to detect this type of cancer. This will be the first time that PARPi-FL is being tried in people. First, the investigators will test the safety of PARPi-FL at different doses to find out what effects, if any, it has on people. The investigators will also see which amount of PARPi-FL is best suited to detect cancers of the mouth and tongue.

This is an open label, investigator initiated single arm phase I/II study. The concentration for imaging OSCC is defined in Phase I. Phase II will then use this concentration to obtain preliminary data on the sensivity of PARPi-FL to detect and delinate OSCC.

A Dye for the Detection of Cancer of the Tongue and Mouth

A Phase I/II Study of the Fluorescent PARP1 Binding Imaging Agent PARPi-FL in Patients With Oral Squamous Cell Carcinomas

toxicity data relevant to study interventions (CTCAE v 4.0)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors	NCT02975739	Radioisotopes Head and Neck N...	Holmium-166 (po...	18 Years -	UMC Utrecht
Feasibility of Holmium-166 Micro Brachytherapy in Head and Neck Tumors	NCT02975739	Radioisotopes Head and Neck N...	Holmium-166 (po...	18 Years -	UMC Utrecht
CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT	NCT01760811	Squamous Cell C...	Erbitux,merck s...	18 Years - 80 Years	Rabin Medical Center
Spectroscopic Analysis of Tongue Tumor Samples.	NCT05104619	Mass Spectrosco... Molecular Profi... Surgical Margin... Squamous Cell C... Oral Cavity Tongue	tongue surgery	18 Years -	Centre Hospitalier Universitaire, Amiens
CETUXIMAB Given for 3 Weeks as Neoadjuvant Treatment in Locally Advanced Tongue Cancer ; A NEW PARADIGM OF TREATMENT	NCT01760811	Squamous Cell C...	Erbitux,merck s...	18 Years - 80 Years	Rabin Medical Center
Combining Tongue and Gastric Cancer Cascade With Artificial Intelligence	NCT05368636	Artificial Inte... Tongue Gastric Cancer		40 Years - 80 Years	Shandong University
Therapeutic Efficacy of Quercetin Versus Its Encapsulated Nanoparticle on Tongue Squamous Cell Carcinoma Cell Line	NCT05456022	Oral Cancer	Quercetin 3,3',... Quercetin-encap... Doxorubicin che...	-	Cairo University
Spectroscopic Analysis of Tongue Tumor Samples.	NCT05104619	Mass Spectrosco... Molecular Profi... Surgical Margin... Squamous Cell C... Oral Cavity Tongue	tongue surgery	18 Years -	Centre Hospitalier Universitaire, Amiens
INtra-operative Evaluation of a Novel FLUorescENt C-mEt Tracer in Penile and Tongue	NCT04574427	Head and Neck C... Penile Cancer		18 Years -	The Netherlands Cancer Institute
Combining Tongue and Gastric Cancer Cascade With Artificial Intelligence	NCT05368636	Artificial Inte... Tongue Gastric Cancer		40 Years - 80 Years	Shandong University
A Dye for the Detection of Cancer of the Tongue and Mouth	NCT03085147	Oral Squamous C...	Olaparib	18 Years -	Memorial Sloan Kettering Cancer Center

Spots Global Cancer Trial Database for tongue

Every month we try and update this database with for tongue 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 tongue

Every month we try and update this database with for tongue 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 tongue 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.