Clinical trials: sponsored by IRCCS San Raffaele
Subjective Cognitive Decline, Alzheimer Disease
Using Artificial Intelligence to Detect Early Signs of Alzheimer's Disease in People With Memory Concerns
AHEAD is a prospective, longitudinal, risk-stratified single-arm interventional study enrolling 300 patients with Subjective Cognitive Decline (SCD) at IRCCS San Raffaele Hospital, Milan, Italy.
- Conditions
- Subjective Cognitive Decline, Alzheimer Disease, Mild Cognitive Impairment, Cognitive Decline
- Trial name
- AHEAD (NCT07652931)
- Testing
- High-frequency Transcranial Magnetic Stimulation (TMS), Digital Cognitive Training, Structured Physical Exercise
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- IRCCS San Raffaele
Complicated Diverticulitis, Acute Diverticulitis
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
The AIDE/OBS study is a multicenter, observational, non-interventional study designed to collect standardized clinical, radiological, intraoperative visual, and surgical reasoning data from adult patients undergoing non-elective…
- Conditions
- Complicated Diverticulitis, Acute Diverticulitis, Peritonitis, Perforated Diverticulitis
- Trial name
- AIDE/OBS/2025 (NCT07651072)
- Testing
- Primary anastomosis, Hartmann's procedure
- Where
- Italy
- Volunteers
- 150 people
- Sponsor
- IRCCS San Raffaele Roma
Parkinson Disease, Alzheimer Disease
Biomarkers in Alzheimer's and Parkinson's Diseases for IA
Investigate whether endogenous and exogenous risk factors, the presence of pathological amyloid aggregates and alpha-synuclein in the CSF, brain connectivity, and some clinical and biological indices such as vigilance, general…
- Conditions
- Parkinson Disease, Alzheimer Disease, Mild Cognitive Impairment, Dementia
- Trial name
- PREDICT-NEUR (NCT07651085)
- Testing
- Neuropsycological assesment, cerebral MRI, EEG
- Where
- Italy
- Volunteers
- 65 people
- Sponsor
- IRCCS San Raffaele Roma
Episodic Migraine, Chronic Migraine
i-NEED: NEw migrainE Drugs Database
Approved by the Food and Drug Administration (FDA) and the European Medicine Agency (EMA) starting in 2018, anti-CGRP monoclonal antibodies (anti-CGRP mAbs) represent the first true revolution in the preventive treatment of…
- Conditions
- Episodic Migraine, Chronic Migraine, Medication Overuse Headache
- Trial name
- i-NEED (NCT07103694)
- Testing
- anti-CGRP monoclonal antibodies, gepants, combination of sumatriptan and naproxen
- Where
- 2 sites in Italy
- Volunteers
- 2,641 people
- Sponsor
- IRCCS San Raffaele Roma
Suspicion of Prostate Cancer With a Positive Multiparametric Magnetic Resonance of the Prostate
Optimizing the Number of Systematic COres During a MRI Target Biopsy
This is a multicentre, paired-cohort, prospective, controlled study. The patient with a suspicion of PCa and a concomitant positive mpMRI (defined as presence of one lesion PI-RADS ≥ 3) will receive a MRI-TBx (4 target cores).
- Trial name
- NCT04183699
- Testing
- Prostate biopsy
- Where
- Italy
- Volunteers
- 126 people
- Sponsor
- IRCCS San Raffaele
Stroke, Parkinson Disease
Evaluation of a Soft Elbow Exoskeleton and a Haptic Armband in Post-stroke and Parkinson's Disease Patients
This pilot feasibility study will evaluate a wearable soft elbow exosuit and a haptic forearm bracelet for upper-limb neurorehabilitation in people with stroke and Parkinson's disease.
- Trial name
- EMBA-IP (NCT07637123)
- Testing
- Wearable upper-limb rehabilitation devices
- Where
- 2 sites in Italy
- Volunteers
- 45 people
- Sponsor
- IRCCS San Raffaele Roma
CAH - Congenital Adrenal Hyperplasia
Hydrocortisone Modified-release in Adults: Real-world Monitoring of Longitudinal Outcomes in coNgenital Adrenal hYperplasia
Classic congenital adrenal hyperplasia (CAH) is an autosomal recessive genetic disorder caused by a defect in the enzyme cascade regulating adrenal steroidogenesis; in approximately 95% of cases the defect is located in CYP21A2…
- Trial name
- HARMONY (NCT07622030)
- Volunteers
- 100 people
- Sponsor
- IRCCS San Raffaele
Hemorrhage Brain
Delayed Intracranial Hemorrhages in Patients With Minor Head Injury on Anticoagulant or Dual Anti-platelet Therapy
Retrospective observational study on a cohort of 2 years to evaluate the incidence of brain hemorrhage present at control head CT scan executed after routine 24h observation period of ED stay in patients with minor head injury on…
- Trial name
- NCT07631936
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- IRCCS San Raffaele
Menopause, Menopausal Hormone Therapy
A Retrospective and Prospective Clinical Registry for Data Collection of Perimenopausal, Menopausal and Premature Ovarian Insufficiency Women
This study is designed as on observational, retrospective, and prospective clinical registry aimed at collecting comprehensive real-world data on women in perimenopause, menopause, and with premature ovarian insufficiency (POI)…
- Conditions
- Menopause, Menopausal Hormone Therapy, Menopause Surgical, Menopause Related Conditions
- Trial name
- NCT07606326
- Volunteers
- 5,000 people
- Sponsor
- IRCCS San Raffaele
Breast Cancer Early Stage Breast Cancer (Stage 1-3)
ON-treatment Single-cell Analysis for the Identification of Early Tumor Response Biomarkers on Prospective Collected Serial Tumor Biopsies in Triple Negative Breast Cancer Patient During Standard Neoadjuvant Chemo-immunotherapy
This study explores early breast cancer, focusing on triple-negative and high-risk luminal subtypes. It combines single-cell RNA sequencing and spatial imaging of tumor samples collected at different time points during treatment.
- Trial name
- ONSET (NCT07597642)
- Testing
- on treatment biopsy (after C1)
- Where
- Italy
- Volunteers
- 55 people
- Sponsor
- IRCCS San Raffaele
Brain Tumors
Diagnostic Performance and Quantitative Analysis of [18F]FET PET in Brain Tumours
This is a retrospective study encompassing all [18F]FET PET scans performed at our centre. By analysing both static and dynamic scans, conducting in-depth kinetic modelling, and comparing quantitative parameters across different…
- Trial name
- FET-BRAIN-DX (NCT07599917)
- Volunteers
- 69 people
- Sponsor
- IRCCS San Raffaele
Primary Progressive Aphasia(PPA)
Targeted Transcranial Magnetic Stimulation to Improve Language and Speech in Patients With Primary Progressive Aphasia
This is a monocenter randomized controlled clinical trial with cross-over arm - assessor blinded. The aims is investigating the effects of the speech language therapy (SLT) alone vs SLT + non-invasive brain stimulation (STIM)…
- Trial name
- NCT06921265
- Testing
- Training with Speech Language Therapy, Standard rTMS, Targeted rTMS
- Where
- Italy
- Volunteers
- 75 people, healthy volunteers welcome
- Sponsor
- IRCCS San Raffaele
Prostate Cancer
High-resolution Intra-operative PSMA PET-CT in Prostate Cancer
This is a Single-center, diagnostic open-label prospective, pilot study in a total of 10 patients affected by Prostate cancer (PCa) with a risk of lymph node invasion (LNI) higher than 5% and candidates for a robot-assisted…
- Trial name
- NCT06298838
- Testing
- AURA10® Specimen PET/CT imager
- Volunteers
- 10 people
- Sponsor
- IRCCS San Raffaele
Prostate Cancer
Artificial Intelligence & Prostate Cancer
This is a single center, blinded (the mpMRI will be read by expert personnel not aware of the patient's diagnosis ), retrospective study.
- Trial name
- QUANTIB (NCT06298305)
- Testing
- Quantib prostate (Quantib B.V. Rotterdam, The Netherlands) software
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- IRCCS San Raffaele
Breast Cancer, Operable Breast Cancer
EXpander-based Versus Direct to Implant PRE-pectoral Breast Reconstruction: a Comparative Analysis of Surgical Outcomes
Recent advances in breast surgery, together with the increasing adoption of conservative surgical approaches, have renewed interest in pre-pectoral implant-based breast reconstruction.
- Trial name
- EXPRESSO (NCT07593651)
- Volunteers
- 276 people
- Sponsor
- IRCCS San Raffaele
Prostate Cancer Adenocarcinoma
Multi-omics Analysis of Prostate Derived Extracellular Vesicles: an Observational Retrospective Study for Prostate Cancer Diagnosis and Monitoring
Prostate cancer (PCa) is the most commonly diagnosed malignancy in men and a leading cause of cancer-related mortality worldwide.
- Trial name
- EXOMAP (NCT07355985)
- Volunteers
- 100 people
- Sponsor
- IRCCS San Raffaele
Prostate Cancer, Molecular Imaging
Molecular Profiling of MRI-PSMA PET Discordance in Prostate Cancer
MRI and PSMA-PET are highly sensitive imaging tools for prostate cancer, yet they often detect different lesions. These discordant findings pose clinical uncertainty because their biological significance is unclear.
- Conditions
- Prostate Cancer, Molecular Imaging, Transcriptomics, RNA
- Trial name
- MP-PET-MRI (NCT07485257)
- Where
- Italy
- Volunteers
- 30 people
- Sponsor
- IRCCS San Raffaele
Prostate Cancer
Phase 2 Study of Neoadjuvant PEMbrolizumab Before Radical PROstatectomy in High-risk Prostate Cancer Patients
This is a phase 2, open-label, non-randomized, single-arm study in patients with high-risk PCa diagnosed with prostate biopsy and undergoing RP and ePLND.
- Trial name
- PEM-PRO (NCT04565496)
- Testing
- Pembrolizumab
- Where
- 2 sites in Italy
- Sponsor
- IRCCS San Raffaele
Prostate Cancer
A Tailored Polygenic Risk Score for Predicting Progression in Prostate Cancer Under Active Surveillance
Prostate cancer is the most common malignancy in men, and in patients with low-risk disease, active surveillance represents the preferred initial approach to avoid unnecessary treatments.
- Trial name
- PRS-AS (NCT07491406)
- Where
- Italy
- Volunteers
- 185 people
- Sponsor
- IRCCS San Raffaele
Gastrointestinal Cancer
EAT-ING: Enhancing Anticancer Treatment Safety Via Immunomodulatory Nutritional Support in Advanced Gastrointestinal Cancers
The use of immunomodulants in patients with GI cancer has been progressively gaining attention in the last years, as a high-calorie-high-protein nutritional blend enriched in immunonutrients has shown efficacy in several studies…
- Trial name
- EAT-ING (NCT07590622)
- Testing
- LH BLU, ONS
- Volunteers
- 88 people
- Sponsor
- IRCCS San Raffaele