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Clinical Trials in Italy / NCT06599957
Recruiting Observational

Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy

NCT06599957 · tracked via the Priya Life Science Italy tracker
Sponsor
Istituto Ortopedico Rizzoli
Phase
Observational
Started
2024-08-30
Last updated
2025-09-22

Condition(s) studied

Bone and Soft Tissue Tumors

Study summary

DEEPLY aims to improve sarcoma therapy by the development of an innovative nanophotonic delivery approach to be applied in the future as an integrated local therapy for patients with inoperable tumors or with oligometastases. The major aim of the project is the development of innovative nanocarriers loaded with chemotherapeutic agents, whose delivery will be improved by the use of an optic fiber (optoporation). After the synthesis, and characterization of NPs, a prototype will be produced and preclinically validated on patient-derived biological material. This wide comprehensive methodological approach will ensure the obtainment of robust data to be faster exploited toward clinical applications.

Eligibility

Sex
ALL
Min age
2 Years
Max age
85 Years
Healthy volunteers
No
Inclusion Criteria: * Patients eligible for the study will be male or female, with an age ranging from 0- to 85 years, undergoing surgery or biopsy for STSs or BSs including osteosarcomas. * Included patients may have undergone or may be still in treatment with chemotherapy (also neo-adjuvant settings), targeted therapy, radiotherapy, or combination therapy. * IRST will enroll only adult patients (age \> 18 years). * Signed informed consent from all subjects enrolled in the study. IOR patients will have to sign both the specific project Informed Consent and the IOR Biobank Informed consent. Exclusion Criteria: * Patients not affected by STSs or BSs will be excluded from the study, as well as patients with multiple primary tumors.

Primary outcome measure(s)

  • Primary Objective — 2 years
    The primary aim of the study will be to determine on primary cells or explants the efficacy of the innovative nanotechnology formulations established in the project.

Trial sites (2)

FacilityCityRegionStatus
Istituto Ortopedico Rizzoli-OSOTT Bologna Emilia-Romagna Recruiting
IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola Emilia-Romagna Recruiting

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Assessment of Periprosthetic Bone Mineral Density in Patients Undergoing Total Knee Prosthesis of Different Design Recruiting
Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis Recruiting
Identification of Circulating Biomarkers Associated With Extracellular Vesicles in Sarcomas Recruiting
Prospective Observational Cohort Study of Cardiac Structure and Function in Children and Adults With Osteogenesis Imperfecta Recruiting

Other trials for the same condition

Development of Innovative Preclinical Ex Vivo Models for the Study of Sarcomas and Metastases From Solid Tumors Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06599957 on ClinicalTrials.gov ↗ ← All trials in Italy