New drug delivery method for treating sarcoma
Innovative Drug Delivery Nanophotonic Platform for Implementation of Sarcoma Therapy
Istituto Ortopedico Rizzoli · NCT06599957
This study is testing a new way to deliver cancer treatment directly to hard-to-reach sarcoma tumors using tiny particles and light to see if it works better for patients with inoperable tumors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 2 Years to 85 Years |
| Sex | All |
| Sponsor | Istituto Ortopedico Rizzoli (other) |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Bologna, Emilia-Romagna and 1 other locations) |
| Trial ID | NCT06599957 on ClinicalTrials.gov |
What this trial studies
This project aims to enhance sarcoma therapy through the development of a novel nanophotonic delivery system designed for patients with inoperable tumors or oligometastases. The approach involves creating innovative nanocarriers loaded with chemotherapeutic agents, which will be delivered more effectively using an optic fiber technique known as optoporation. Following the synthesis and characterization of these nanoparticles, a prototype will be produced and validated preclinically using patient-derived biological material. This comprehensive methodology is intended to generate robust data that can be rapidly translated into clinical applications.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 0 to 85 years with soft tissue sarcomas or bone sarcomas, including osteosarcomas, who are undergoing surgery or biopsy.
Not a fit: Patients not affected by soft tissue sarcomas or bone sarcomas, as well as those with multiple primary tumors, will not benefit from this study.
Why it matters
Potential benefit: If successful, this innovative delivery method could significantly improve treatment outcomes for patients with difficult-to-treat sarcomas.
How similar studies have performed: While this approach is innovative, similar studies exploring nanocarrier systems have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bologna, Emilia-Romagna and 1 other locations
- Istituto Ortopedico Rizzoli-OSOTT — Bologna, Emilia-Romagna, Italy (RECRUITING)
- IRCCS Istituto Romagnolo per lo Studio dei Tumori Dino Amadori — Meldola, Emilia-Romagna, Italy (RECRUITING)
Study contacts
- Study coordinator: Toni Ibrahim, MD Oncologist
- Email: toni.ibrahim@ior.it
- Phone: +39 0516366199
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bone and Soft Tissue Tumors, sarcomas, nanocarriers, therapy, nanophotonic