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Head and Neck Neoplasms clinical trials

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NCT ID: NCT05081531 Recruiting - Clinical trials for Head and Neck Cancer

AI for Head Neck Cancer Treated With Adaptive RadioTherapy (RadiomicART)

RadiomicArt
Start date: October 5, 2021
Phase: N/A
Study type: Interventional

Current clinical management algorithms for squamous cell carcinoma of head and neck (HNSCC) involve the use of surgery and / or radiotherapy (RT) depending on the stage of the disease at diagnosis. Radical RT, exclusive or in combination with systemic therapy, represents an effective therapeutic option according to the international guidelines. Despite the recent technological advancements in the field of RT, about 30-50% of patients will develop locoregional failure after primary treatment . Moreover, although the development of Intensity modulated radiation therapy (IMRT) and Volumetric modulated arc therapy (VMAT) techniques allowed a greater sparing of dose on healthy tissues, radiation-induced toxicity still represents a relevant concern, impacting on quality of life. The continuous effort of personalized medicine has the goal of improving patient's outcome, in terms of both disease's control and pattern of toxicity. Advanced imaging modalities appear to play an essential role in the customization of the radiation treatment as shown through the use of Adaptive Radiotherapy (ART) and radiomic. With ART we mean the adaptation of tumor volumes and surrounding organs at risk (OARs) to the shrinkage and patient emaciation during RT treatment. Adaptive radiotherapy (ART) includes techniques that allow knowledge of patient-specific anatomical variations informed by Image-guided radiotherapies (IGRTs) to feedback into the plan and dose-delivery optimization during the treatment course. Radiomic is the extraction of quantitative features from medical images to characterize tumor pathology or heterogeneity. Radiomic features extracted from medical images can be used as input features to create a machine learning model able to predict survival, and to guide treatment thanks to its predictive value in view of therapy personalization. The combination of both ART and radiomic analysis could potentially be considered a further advance in the personalization of oncological treatments, and in particular for radiation treatments. For this reason, the investigators designed the present research project with the aim to prospectively evaluate a machine learning-based radiomic approach to predict outcome and toxicity of HNSCC patients treated with ART by mean of CT, MRI and PET-scan.

NCT ID: NCT05077072 Recruiting - Clinical trials for Head and Neck Carcinoma

Interdisciplinary Interventions to Address Pain Management Among Head and Neck Cancer Patients

Start date: October 8, 2021
Phase: Phase 2
Study type: Interventional

This phase II trial compares different pain management interventions (standard of care [SOC], neurofeedback [NFB] training, and compassionate high alert team [CHAT]) in patients diagnosed with head and neck cancer who are at risk of developing non-medical opioid use (NMOU). The current standard treatment includes regular clinic visits and supportive care and counseling (including topics like patient-doctor communication, cancer care goals, financial issues counseling, and other topics). NFB training is a type of therapy that uses an electroencephalograph (EEG) and a computer software program to measure brain wave activity. The goal of NFB is to help teach patients with pain how to change their own brain waves to lower their feelings of pain and help improve their quality of life. CHAT is a supportive care intervention that includes symptom and pain management, counseling (about pain, symptoms, opioid use and safety, stress, and quality of life), and support for patients and their family members. NFB and CHAT may help to manage pain and lower patient use of opioids.

NCT ID: NCT05075980 Recruiting - Clinical trials for Head and Neck Carcinoma

HEADLIGHT: Hypofractionated Proton Therapy for Head and Neck Cancers

Start date: February 16, 2022
Phase: Phase 2
Study type: Interventional

This clinical trial tests whether intensity modulated proton therapy after surgery works to shrink tumors in patients with head and neck cancer. Radiation therapy uses high energy protons to kill tumor cells and shrink tumors.

NCT ID: NCT05073809 Withdrawn - Clinical trials for Head and Neck Cancer

Photoacoustic Imaging of Head and Neck Tumours

Start date: September 29, 2022
Phase:
Study type: Observational

Cancer is the commonest cause of death in the UK, and a national and international healthcare priority. Survival in the UK is relatively poor vs. European comparators1, meaning early tumour detection and accurate clinical assessment is particularly important to improve outcomes. Treatment fundamentally depends on tumour staging, both of the local cancer and of draining lymph nodes (LN), as well as distant spread of disease i.e. TNM stage (tumour (T), node (N) and metastases (M). However, current non-invasive pre-operative imaging technologies of ultrasound (US), computed tomography (CT) and magnetic resonance imaging (MRI) are limited in sensitivity and specificity for nodal assessment, either missing disease or subjecting patients to unnecessary additional invasive biopsies or surgery. A simple, rapid, non-invasive tool to assess primary tumours and LN involvement would be of great clinical value. One candidate technology is photoacoustic tomography (PAT), a relatively novel modality that combines exquisite spatial resolution with the ability to image multiple biological tissues, including blood, water and lipid. To date, PAT has been most successful in imaging the vasculature, which is of particular interest for oncological imaging because one of the key hallmarks of cancer is the development of new, abnormal blood vessels (neoangiogenesis). The high sensitivity for superficial imaging with PAT means that head and neck tumours and neck LN are readily amenable for assessment. In this cohort of patients, those with oral cavity tumours, in particular tumours arising from the lining of the tongue, would be readily accessible for direct scanning.

NCT ID: NCT05070247 Recruiting - Breast Cancer Clinical Trials

A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

Start date: April 14, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors. The aims of the study are: - to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab. - to assess the anti-tumor effects of TAK-500, when given alone and when given with pembrolizumab, in adults with locally advanced or metastatic solid tumors. Participants may receive TAK-500 for up to 1 year. Participants may continue with their treatment if they have continuing benefit and if this is approved by their study doctor. Participants who are receiving TAK-500 either alone or with pembrolizumab will continue with their treatment until their disease progresses or until they or their study doctor decide they should stop this treatment.

NCT ID: NCT05068687 Completed - Clinical trials for Head and Neck Neoplasms

Peroperative Assessment of Malignancies of the Head and Neck Using High-resolution 18F-FDG-PET/CT

Start date: August 28, 2020
Phase: N/A
Study type: Interventional

In this study, patients diagnosed with a pathology-proven malignancy of the head and neck will receive a routine clinical activity of 18F-FDG ((18)F-luorodeoxyglucose) before undergoing standard of care surgical resection of the malignancy. Following the resection, the 18F-FDG-infused malignancy will be investigated utilizing a novel high-resolution Positron Emission Tomography (PET) and Computed Tomography (CT) scan. Slicing of the malignancy will be followed by additional PET/CT-scanning and autoradiography of the sliced specimen. The results found during image analysis will be compared to the results of the gold standard of histopathology. As this is no approved way of assessing the tumour's margin, the conclusion of the scan will not be used as a method for changing the patients' treatment.

NCT ID: NCT05063552 Recruiting - Clinical trials for Recurrent Head and Neck Squamous Cell Carcinoma

Testing the Use of Investigational Drugs Atezolizumab and/or Bevacizumab With or Without Standard Chemotherapy in the Second-Line Treatment of Advanced-Stage Head and Neck Cancers

Start date: March 13, 2023
Phase: Phase 2/Phase 3
Study type: Interventional

This phase II/III compares the standard therapy (chemotherapy plus cetuximab) versus adding bevacizumab to standard chemotherapy, versus combination of just bevacizumab and atezolizumab in treating patients with head and neck cancer that has spread to other places in the body (metastatic or advanced stage) or has come back after prior treatment (recurrent). Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Cetuximab is in a class of medications called monoclonal antibodies. It binds to a protein called EGFR, which is found on some types of cancer cells. This may help keep cancer cells from growing. Cisplatin and carboplatin are in a class of chemotherapy medications known as platinum-containing compounds. They work by killing, stopping, or slowing the growth of cancer cells. Docetaxel is in a class of chemotherapy medications called taxanes. It stops cancer cells from growing and dividing and may kill them. The addition of bevacizumab to standard chemotherapy or combination therapy with bevacizumab and atezolizumab may be better than standard chemotherapy plus cetuximab in treating patients with recurrent/metastatic head and neck cancers.

NCT ID: NCT05061316 Active, not recruiting - Clinical trials for Cancer of Head and Neck

The Gut Microbiome as an Indicator of Readiness for Head & Neck Cancer Surgery

Start date: March 11, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is to understand how a pre-operative nutritional intervention alters the gut microbiome and improves outcomes after major head and neck cancer surgery.

NCT ID: NCT05060432 Active, not recruiting - Lung Cancer Clinical Trials

Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors

TIG-006
Start date: September 6, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multicenter, open-label, phase I/II basket study, evaluating the safety, tolerability, RP2D, pharmacokinetics, pharmacodynamics and antitumor activity of EOS-448 (also known as GSK4428859A or belrestotug) combined with standard of care and/or with investigational therapies in participants with advanced solid tumors.

NCT ID: NCT05059340 Completed - Clinical trials for Head and Neck Cancer

Study to Explore Post Surgical Outcomes Using Point-of-Gaze, Electromyography and Elastography of the SCM

Start date: November 2, 2020
Phase:
Study type: Observational

The side effects following post surgical neck dissection treatment for tumours in the head and neck (HN) region are weakness of the shoulder and neck muscles, numbness and reduced sensation around the neck and shoulder region and a general impact on the participant's overall fitness. While survival has been emphasized as an important outcome, recovery of treatment-related morbidity and return to pre-treatment quality of life (QOL) for participants after cancer treatment is equally important. Sternocleidomastoid (SCM) muscle functions to turn the head to the left or right. In particular while performing neck dissections, SCM dissection is a common step. The side effects of SCM dissection is a stiff neck or reduced neck movements. To objectively measure the outcome of the SCM muscle function, it is necessary to determine what is the normal range of motion in healthy subjects turning to the left and right to look at objects in a specific location or Point-of gaze (POG) procedure, as well as the Electromyography (EMG) of the SCM during the movement. In this normative study, 20 healthy subjects will be recruited to perform this POG assessment as well as EMG and Elastography (ETG) testing of the SCM on the left and right side. Outcome measures will include 1. neck range of motion for flexion, side flexion and rotation 2. EMG activation patterns for SCM 2) muscle thickness & stiffness (as determined by grey scale ultrasound (US) and ETG, respectively) of the SCM The investigators hypothesize that there will not be any significant differences of POG, EMG and ETG measurements between the left and right side of the SCM in healthy subjects.