University Hospital, Strasbourg, France — Biomedical Watch V2

Traitements12programmes

Essais7liés

Publications11liées

SourceDBlocale

Traitements

12

Molécule	Indication / population	Phase	Objectif	Pays	Résultat
CEREB — Evolution of the Cognitive Profile and Quality of Life of Adult Patients Suffering From Severe Migraines Under Preventive TreatmentIn chronic migraine, we routinely use innovative treatments such as peri-cranial injections of botulinum toxin type A according to the PREEMPT protocol, or intravenous Eptinezumab, both targeting the Calcitonin Gene-Related Peptide (CGRP). We observe significant improvement in 70-80% of our patients after one year of treatment, corresponding to at least a 30-50% reduction in the number of migraines per month, together with improvements in anxiety and depression comorbidities (HADS), catastrophizing scores (PCS), and the impact of migraines on quality of life (HIT-6). Our main hypothesis, based on our clinical experience and the literature, is that the cognitive profile of these adult patients-particularly attention and memory, as assessed by a validated self-report questionnaire-improves following treatment with botulinum toxin type A administered according to the PREEMPT protocol or intravenous anti-CGRP antibody infusions (Eptinezumab), alongside improvement in migraine disease activity (number of migraines per month), after one year of treatment.	Migraine	Non applicable	À vérifier	France	À vérifier
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate TissuePrimary purpose : Evaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer. Primary Objective: Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up. Secondary Objectives: 1. Biochemical response 2. Presence of any CSC on biopsy at 1- and 2-year follow-up 3. Radical treatment free survival 4. Adverse events, clinical tolerance 5. Urinary continence 6. Erectile function 7. Quality of life	Cancer	Non applicable	À vérifier	France	À vérifier
MRI in Ductal Carcinoma in Situ (DCIS)Compare the estimate of the lesional size in MRI to that in mammography, taking as a reference the definitive anatomo-pathological size	Cancer	À vérifier	À vérifier	France	À vérifier
Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for InjectionCentra nervous system (CNF) damage in multiple sclerosis (MS), are mainly attributed to myelin destruction, axonal abnormalities and subsequent degeneration, and are responsible for serious deficiencies. Current therapies are focused on the treatment of inflammation with several types of anti-inflammatory agents. However, there is an urgent need for innovative therapies promoting neuroregeneration and particularly myelin repair. It has been demonstrated that testosterone can act through neural androgen receptors to promote proliferation and differentiation of oligodendrocyte precursors into mature oligodendrocytes in a cuprizone-induced animal model of demyelination. The rare clinical trials on testosterone are mainly exploratory. Here, we sought to demonstrate an effect of testosterone supplementation in testosterone-deficient patients in a multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial. The main objective will be to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyzes. As secondary objectives, we would like to study the impact of testosterone supplementation on other conventional and unconventional MRI parameters and on clinical outcomes (cognition, fatigue, quality of life, impact on work / activity and anxiety / depression).	SEP	Phase 2	Remyélinisation	France	À vérifier
SEP-RR — Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMSMultiple Sclerosis (MS) is a chronic, autoimmune, neurodegenerative disease; clinical events are mainly attributed to myelin destruction and inflammatory of the central nervous system. The diagnosis resides in clinical and radiological criteria according to 2017 McDonald criteria. Once the diagnosis of MS has been made, treatment should be initiated promptly, in order to delay the onset of severe disability in the long-term, even more ocrelizumab are a treatment of high efficacy. Ocrelizumab is used as a first-line or second-line treatment in Relapsing Remitting MS (RRMS) It is an anti-CD20 monoclonal antibody that provides rapid depletion of circulating CD20+ B lymphocytes by complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity. The main objective is the retrospective evaluation of the impact of ocrelizumab on the outcome of MS. The secondary objective is the search of predictive factors of response to treatment.	SEP	À vérifier	Immunomodulation	France	À vérifier
UFOGUIDE "patient transducer"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.	Cancer	Non applicable	À vérifier	France	À vérifier
MRI in Ductal Carcinoma in Situ (DCIS)Compare the estimate of the lesional size in MRI to that in mammography, taking as a reference the definitive anatomo-pathological size	Cancer	À vérifier	À vérifier	France	À vérifier
SEP-RR — Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMSMultiple Sclerosis (MS) is a chronic, autoimmune, neurodegenerative disease; clinical events are mainly attributed to myelin destruction and inflammatory of the central nervous system. The diagnosis resides in clinical and radiological criteria according to 2017 McDonald criteria. Once the diagnosis of MS has been made, treatment should be initiated promptly, in order to delay the onset of severe disability in the long-term, even more ocrelizumab are a treatment of high efficacy. Ocrelizumab is used as a first-line or second-line treatment in Relapsing Remitting MS (RRMS) It is an anti-CD20 monoclonal antibody that provides rapid depletion of circulating CD20+ B lymphocytes by complement-dependent cytotoxicity and antibody-dependent cellular cytotoxicity. The main objective is the retrospective evaluation of the impact of ocrelizumab on the outcome of MS. The secondary objective is the search of predictive factors of response to treatment.	SEP	À vérifier	Immunomodulation	France	À vérifier
Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for InjectionCentra nervous system (CNF) damage in multiple sclerosis (MS), are mainly attributed to myelin destruction, axonal abnormalities and subsequent degeneration, and are responsible for serious deficiencies. Current therapies are focused on the treatment of inflammation with several types of anti-inflammatory agents. However, there is an urgent need for innovative therapies promoting neuroregeneration and particularly myelin repair. It has been demonstrated that testosterone can act through neural androgen receptors to promote proliferation and differentiation of oligodendrocyte precursors into mature oligodendrocytes in a cuprizone-induced animal model of demyelination. The rare clinical trials on testosterone are mainly exploratory. Here, we sought to demonstrate an effect of testosterone supplementation in testosterone-deficient patients in a multicenter, randomized, parallel-group, double-blind, placebo-controlled phase 2 trial. The main objective will be to determine the neuroprotective and remyelinating effects of testosterone using tensor diffusion imaging techniques and thalamic atrophy analyzes. As secondary objectives, we would like to study the impact of testosterone supplementation on other conventional and unconventional MRI parameters and on clinical outcomes (cognition, fatigue, quality of life, impact on work / activity and anxiety / depression).	SEP	Phase 2	Remyélinisation	France	À vérifier
CEREB — Evolution of the Cognitive Profile and Quality of Life of Adult Patients Suffering From Severe Migraines Under Preventive TreatmentIn chronic migraine, we routinely use innovative treatments such as peri-cranial injections of botulinum toxin type A according to the PREEMPT protocol, or intravenous Eptinezumab, both targeting the Calcitonin Gene-Related Peptide (CGRP). We observe significant improvement in 70-80% of our patients after one year of treatment, corresponding to at least a 30-50% reduction in the number of migraines per month, together with improvements in anxiety and depression comorbidities (HADS), catastrophizing scores (PCS), and the impact of migraines on quality of life (HIT-6). Our main hypothesis, based on our clinical experience and the literature, is that the cognitive profile of these adult patients-particularly attention and memory, as assessed by a validated self-report questionnaire-improves following treatment with botulinum toxin type A administered according to the PREEMPT protocol or intravenous anti-CGRP antibody infusions (Eptinezumab), alongside improvement in migraine disease activity (number of migraines per month), after one year of treatment.	Migraine	Non applicable	À vérifier	France	À vérifier
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate TissuePrimary purpose : Evaluation of the efficiency and safety of an alternative global prostate treatment in localized prostate cancer. Primary Objective: Absence of clinically significant cancer (CSC) on control biopsy at 1-year follow-up. Secondary Objectives: 1. Biochemical response 2. Presence of any CSC on biopsy at 1- and 2-year follow-up 3. Radical treatment free survival 4. Adverse events, clinical tolerance 5. Urinary continence 6. Erectile function 7. Quality of life	Cancer	Non applicable	À vérifier	France	À vérifier
UFOGUIDE "patient transducer"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.	Cancer	Non applicable	À vérifier	France	À vérifier

Essais cliniques

7

Molécule	Indication / population	Phase	NCT	Titre	Statut
Cladribine	SEP	À vérifier	NCT06887426	CLADREXIT — Cladribine Tablets as an Exit Therapy Strategy	COMPLETED
UFOGUIDE "patient transducer"	Cancer	Non applicable	NCT04803773	UFOGUIDE — MRI-guided Focused Ultrasound : Feasibility Study for the Treatment of Bone Metastases and osteoïd Osteoma	UNKNOWN
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue	Cancer	Non applicable	NCT03996005	MRI-TULSAP — MRI- Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer	COMPLETED
CEREB — Evolution of the Cognitive Profile and Quality of Life of Adult Patients Suffering From Severe Migraines Under Preventive Treatment	Migraine	Non applicable	NCT07691164	CEREB — Evolution of the Cognitive Profile and Quality of Life of Adult Patients Suffering From Severe Migraines Under Preventive Treatment	NOT_YET_RECRUITING
Nebido® Testosterone Undecanoate 1000 Mg/4 mL Solution for Injection	SEP	Phase 2	NCT03910738	TOTEM-RRMS — TOTEM RRMS : TestOsterone TreatmEnt on Neuroprotection and Myelin Repair in Relapsing Remitting Multiple Sclerosis	RECRUITING
SEP-RR — Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS	SEP	À vérifier	NCT04838015	SEP-RR — Retrospective Study on Registry Data to Evaluate the Impact of Ocrelizumab Used in Routine Care in Patients With RRMS	UNKNOWN
MRI in Ductal Carcinoma in Situ (DCIS)	Cancer	À vérifier	NCT03543397	MRI in Ductal Carcinoma in Situ (DCIS)	UNKNOWN

Publications

11

Molécule	Indication / population	Titre	Journal	Date
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue		Magnetic resonance imaging-guided ultrasound ablation for prostate cancer - A contemporary review of performance.	Frontiers in oncology
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue		MR Imaging-Guided Prostate Cancer Therapies.	Radiologic clinics of North America
Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue		Magnetic resonance imaging-guided transurethral ultrasound ablation for benign prostatic obstruction: 1-year clinical outcomes of a phase II study.	BJU international
MRI in Ductal Carcinoma in Situ (DCIS)		Fewer breast cancers during post-treatment surveillance among patients initially staged using contrast-based imaging.	Breast cancer research and treatment
MRI in Ductal Carcinoma in Situ (DCIS)		Peak Uptake Value on Positron Emission Mammography Addresses Biopsy Sampling Limitations in Stratifying Proliferative Activity of Malignant Non-Mass Enhancement.	The British journal of radiology
MRI in Ductal Carcinoma in Situ (DCIS)		Pathologic characterization of non-mass enhancement lesions of the breast in MRI-guided biopsy.	Human pathology
MRI in Ductal Carcinoma in Situ (DCIS)		Diagnostic performance of Kaiser score, ADC, and their combination for BI-RADS 4 breast lesions: subgroup and misclassification analysis.	Frontiers in oncology
MRI in Ductal Carcinoma in Situ (DCIS)		Complete Imaging Resolution of Ductal Carcinoma In Situ During Osimertinib Therapy for Synchronous EGFR Exon 19-Mutant Non-Small Cell Lung Cancer: A Case Report.	International journal of molecular sciences
MRI in Ductal Carcinoma in Situ (DCIS)		Detection of occult non-mass enhancement in bloody nipple discharge using US/MRI fusion imaging: a case report.	Oxford medical case reports
MRI in Ductal Carcinoma in Situ (DCIS)		Preoperative breast MRI and long-term survival in ductal carcinoma in situ: a propensity score-weighted analysis.	European radiology
MRI in Ductal Carcinoma in Situ (DCIS)		Florid Lobular Carcinoma In Situ (F-LCIS) Showing Predominantly Hypoechoic Masses With Obscured Margins and No Attenuated Posterior Echoes on Ultrasound: A Case Report.	Cureus