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Bone Neoplasms clinical trials

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NCT ID: NCT04947280 Recruiting - Breast Cancer Clinical Trials

Single Arm Phase II Study of Fractionated Stereotatic Radiation Therapy (FSRT) for Bone Metastases in Breast Cancer

Start date: January 1, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

Fractionated stereotatic radiation therapy (FSRT) that very precisely delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. The purpose of this study is to find out if FSRT is safe and effective in the treatment of metastatic spinal tumors of breast cancer.

NCT ID: NCT04859569 Recruiting - Clinical trials for Bone Metastases From Solid Tumors

Efficacy and Safety of LY01011 and Xgeva® in Patients With Bone Metastases From Solid Tumors

Start date: April 30, 2021
Phase: Phase 3
Study type: Interventional

This is a multicenter,randomized, double-blind, active-controlled, parallel-group study comparing efficacy and safety of LY01011 (recombinant anti-RANKL human monoclonal antibody injection) and Xgeva® in patients with bone metastases from solid tumors.

NCT ID: NCT04842071 Recruiting - Infectious Disease Clinical Trials

18F-sodium Fluoride (NaF) PET to Replace Bone Scintigraphy: Safety and Efficacy Assessment

Start date: January 1, 2008
Phase: Phase 3
Study type: Interventional

18F-sodium fluoride (18F-NaF) was already investigated numerous times in the last 40 years as a PET alternative to standard 99m-technetium-derived bone scintigraphy. However, lack of universal tracer availability and higher costs contributed to the failure of 18F-NaF to systematically supplant bone scintigraphy as a standard of care. Recently, an isotope shortage crisis occurred and evidenced the need to have non-reactor-derived alternatives for many nuclear medicine procedures, including bone scintigraphy. Since 18F-NaF is cyclotron-produced, it could become a necessary alternative to bone scintigraphy in case of another worldwide isotope shortage. The study aims to evaluate the safety profile of 18F-NaF injection. Moreover, a patient registry will be compiled in order to perform sub-studies on 18F-NaF diagnostic performance on diverse bone and articular diseases.

NCT ID: NCT04832620 Recruiting - Clinical trials for Magnetic Resonance Imaging

Image Assisted Optimization of Proton Radiation Therapy in Chordomas and Chondrosarcomas

CHIPT
Start date: February 2, 2021
Phase:
Study type: Observational

Rationale: Chordomas and chondrosarcomas located in the axial skeleton are malignant neoplasms of bone. These tumors share the same clinical challenges, as the effect of the disease is more a function of their local aggressiveness than their tendency to metastasize (20% metastasize). The local aggressive behavior can cause debilitating morbidity and mortality by destruction of nearby located critical neurovascular structures. Imaging has, in addition to histopathology, a role in diagnosis and in guiding (neo)adjuvant and definitive treatment. Despite the low sensitivity to radiotherapy, proton radiotherapy has been successfully used as an adjunct to resection or as definitive treatment for aggressive chordomas and chondrosarcomas, making it a standard indication for proton therapy in the Netherlands. Chordomas and chondrosarcomas consist, especially after previous therapy, of non-viable and viable tumor components. Identification of these viable components by functional imaging is important to determine the effect of previous therapy, as change in total tumor volume occurs more than 200 days after change of functional imaging parameters. Objective: The main objective of this study is to determine if functional MRI parameters change within 6 months, and earlier than volumetric changes after start of proton beam therapy. This would allow timely differentiation between affected and unaffected (viable) tumor components, which can be used for therapy adjustment. Secondary objectives: Determine which set of parameters (PET-CT and secondary MRI) can predict clinical outcome (tumor specific mortality, development of metastases, morbidity secondary to tumor activity and morbidity secondary to treatment); determine what type of imaging can accurately identify viable tumor nodules relative to critical anatomical structures; improving understanding of relevance of changing imaging parameters by correlating these with resected tumor. Study design: Prospective cohort study Study population: LUMC patients diagnosed with primary or recurrent chordoma or chondrosarcoma in the axial skeleton. A number of 20 new patients per year is expected. Main study parameters: Volumetric and functional MR imaging parameters including permeability parameters. Secondary parameters are generated by PET-CT (SUV, MTV and TLG), MR (perfusion, permeability and diffusion), therapy (proton beam dose mapping, surgery) and clinical outcome. End points are disease specific survival, progression free survival (including development of metastases), side effects of treatment, and functional outcome (see CRF). In patients who are treated with surgical resection following neo-adjuvant therapy, the surgical specimen will be correlated with imaging findings. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Treatment and clinical management will not be affected in this study, thus the additional burden, risks, and benefits associated with participation in this study are minimal. Two extra MRI and one PET-CT examination will be planned during proton therapy.

NCT ID: NCT04803773 Recruiting - Clinical trials for Painful Bone Metastases

MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma

UFOGUIDE
Start date: January 19, 2021
Phase: N/A
Study type: Interventional

Ufoguide is a prospective single arm open study to assess the feasibility of a new type of HIFU system to treat bone tumors. HIFU is classically delivered by a transducer integrated in the MRI table. This study assesses a new type of approach in which the HIFU transducer is manually placed on the skin of the patient, under the assistance of optical navigation, and held in place by MR-compatible passive arms. The primary goal of this study is to assess the feasibility of heating the tumor accurately with this new HIFU system. The evaluation and monitoring of the treatment will be performed by MR thermometry. Secondary endpoints include the evaluation of clinical efficacy, quality of life and safety.

NCT ID: NCT04720391 Recruiting - Bone Metastases Clinical Trials

Bone Metastases in neurOendocrine NEoplasms: naTural History, Prognostic Impact and Therapeutic Approach (MONET)

MONET
Start date: January 8, 2021
Phase:
Study type: Observational

This is a retrospective/prospective observational multicentric trial on patients with bone metastases from NENs. General objectives: - To trace on a national scale the frequency of bone metastases in patients with neuroendocrine neoplasm (NEN) and their clinical management. - To correlate clinical and biological factors to clinical outcomes. - To centralise and to make homogeneous clinical, pathological, instrumental and therapeutic information. - To set up a database and to acquire biological material for studying predictive and prognostic biomarkers.

NCT ID: NCT04586660 Recruiting - Clinical trials for Giant Cell Tumor of Bone

Study of XGEVA® (Denosumab) in Chinese Adults and Skeletally Mature Adolescents With Giant Cell Tumor of the Bone

Start date: August 17, 2023
Phase: Phase 4
Study type: Interventional

The study aims to evaluate the efficacy of XGEVA® in Chinese participants with giant cell tumor of bone (GCTB).

NCT ID: NCT04568291 Recruiting - Lung Cancer Clinical Trials

CTC in Lung Caner Patients With Bone Metastases

Start date: October 1, 2020
Phase: N/A
Study type: Interventional

1. Evaluate the feasibility of single cell sequencing technology based on three-dimensional bionic capture network; 2. To build a risk prediction model of bone related events based on single cell sequencing; 3. To verify the risk prediction model of bone related events by single cell sequencing; 4. To verify the comprehensive treatment of non-small cell lung cancer ( NSCLC) bone metastases.

NCT ID: NCT04550949 Recruiting - Bone Metastases Clinical Trials

To Evaluate the Efficacy and Safety of QL1206 and Xgeva in Patients With Bone Metastases From Solid Tumors

Start date: April 26, 2019
Phase: Phase 3
Study type: Interventional

A multi-center, randomized, double-blind, comparative study to evaluate the clinical efficacy and safety of QL1206 and Xgeva® in patients with bone metastases from solid tumors.

NCT ID: NCT04442373 Recruiting - Clinical trials for Total Hip Replacement

Impact of Surgical Injury on Haemostatic Tests in Patients Undergoing Total Hip Replacement With Subgroup Analysis of Patients With Neoplasm

I-SIGHT-THR
Start date: January 1, 2020
Phase:
Study type: Observational

Total hip replacement (THR) is associated with extensive tissue injury and considerable blood loss that can be complicated by hyperfibrinolysis with an increased need for blood transfusion. THR in patients with cancer involving the hip joint, can reduce pain and improve or maintain the function and quality of life. However, these patients have an increased likelihood of haemostatic abnormalities, such as thrombosis or extensive blood loss. Rotational thromboelastometry is a point-of-care viscoelastic assay that can provide a measure of coagulation disorders in the above settings, and this is still under review. The objective of this prospective cohort study is to quantitate the changes in clot formation dynamics following THR with a subgroup analysis of patients with cancer.