Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy

Recruiting

• Conditions: Bone and Soft Tissue Tumors

• Registration Number: NCT06599957
• Lead Sponsor: Istituto Ortopedico Rizzoli

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-30
• Status Verified: 2024-09
• Study First Submitted: 2024-09-10
• Study First Submitted QC: 2024-09-12
• Last Update Submitted: 2024-09-12
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-08-30
• Study Completion: 2026-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Secondary Objectives	2 years	The study will have the following secondary aims: I. to establish primary cultures and explants of human STSs and BSs including osteosarcomas, through different in vitro models (2D and 3D); II. to compare the efficacy of innovative NPs with standard and conventional chemotherapeutic drugs employed for the treatment of patients with sarcomas; III. to study the impact of a new delivery system on cancer cell lines, primary cultures and explants derived from fresh surgical specimen.

Trial Locations

Locations (2)

Istituto Ortopedico Rizzoli-OSOTT; 🇮🇹 Bologna, Emilia-Romagna, Italy

IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori; 🇮🇹 Meldola, Emilia-Romagna, Italy