Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy (DEEPLY)

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.

Study Overview

• Status: Recruiting
• Conditions: Bone and Soft Tissue Tumors

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Toni Ibrahim, MD Oncologist; Phone Number: +39 0516366199; Email: toni.ibrahim@ior.it

Study Locations

• Italy
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40136
      • Recruiting
      • Istituto Ortopedico Rizzoli-OSOTT
      • Contact: Toni Ibrahim, MD Oncologist; Phone Number: +39 0516366199; Email: toni.ibrahim@ior.it
    • Meldola, Emilia-Romagna, Italy, 47014
      • Recruiting
      • IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori
      • Contact: Alessandro De Vita, MD; Phone Number: +39 0543739239; Email: alessandro.devita@irst.emr.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients affected by sarcoma and undergoing surgical removal of the tumor or performing a biopsy will be enrolled. Only patients whose resection will provide sufficient tumor tissue that exceed what is necessary for pathological diagnosis characterization and banking will be enrolled.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Bone and soft tissue sarcomas; Patients affected by sarcoma and undergoing surgical removal of the tumor or performing a biopsy will be enrolled. Only patients whose resection will provide sufficient tumor tissue that exceed what is necessary for pathological diagnosis characterization and banking will be enrolled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary Objective	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Secondary Objectives	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.	2 years

Collaborators and Investigators

• Sponsor: Istituto Ortopedico Rizzoli
• Collaborators: Università Degli Studi del Sannio Dipartimento di Ingegneria Benevento; IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: September 10, 2024
• First Submitted That Met QC Criteria: September 12, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 22, 2025
• Last Update Submitted That Met QC Criteria: September 19, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: sarcomas; therapy; nanocarriers; nanophotonic
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Connective and Soft Tissue; Sarcoma; Soft Tissue Neoplasms
• Other Study ID Numbers: DEEPLY; PNRR-POC-2023- 12377696 (Other Grant/Funding Number: Fondi POC PNRR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No