Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy

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.

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Key information

Conditions

Bone and Soft Tissue Tumors Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Sarcoma Soft Tissue Neoplasms

Age range

2 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istituto Ortopedico Rizzoli-OSOTT, Bologna, Emilia-Romagna, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Primary Objective

Time frame: 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 outcomes

Secondary Objectives

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Toni Ibrahim, MD Oncologist

CONTACT

[email protected]

+39 0516366199

Sponsors and collaborators

Lead sponsor

Istituto Ortopedico Rizzoli

Other

Collaborators

IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori Meldola
Università Degli Studi del Sannio Dipartimento di Ingegneria Benevento

Registry information

Acronym: DEEPLY

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Sep 19, 2024
Registry last updated: Sep 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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