Mathematical models for laser treatment of pancreatic tumors
Use of Pre-planning Models for the Guidance of the Endoscopic Ultrasound-guided Laser Ablation of Pancreatic Lesions
This study is testing a new laser treatment for patients with hard-to-treat pancreatic tumors to see if it can help shrink their tumors when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Campus Bio-Medico University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rome, Roma) |
| Trial ID | NCT05549960 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a 980 nm wavelength diode laser for ablating pancreatic lesions in patients with advanced pancreatic ductal adenocarcinoma and other inoperable tumors. The approach combines endoscopic ultrasound guidance with mathematical modeling to optimize treatment efficacy. By targeting tumors that are difficult to reach or treat with conventional methods, the study aims to provide a novel therapeutic option for patients who have not responded to chemotherapy. The study will assess the feasibility and effectiveness of this laser ablation technique in reducing tumor mass.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with histologically confirmed pancreatic ductal adenocarcinoma at stage III or IV, inoperable neuroendocrine tumors, or pancreatic metastasis from renal clear cell cancer.
Not a fit: Patients with contraindications to general anesthesia, significant bleeding disorders, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new, less invasive option for patients with advanced pancreatic cancer, potentially improving their quality of life and survival rates.
How similar studies have performed: Previous studies have shown the feasibility of laser ablation techniques for pancreatic lesions, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologic diagnosis of pancreatic ductal adenocarcinoma (stage III or IV); * Inoperable neuroendocrine tumor; * Pancreatic metastasis from renal clear cell cancer; * Stable situation or progression after chemotherapeutic treatment; * Age \>18 years; * Acquisition of signed Informed Consent; * Performance status 0-1-2 (ECOG). Exclusion Criteria: * Absolute contraindications to general anaesthesia or deep sedation; * Absence of suitable ultrasound acoustic window for the procedure; * Known bleeding disorders that cannot be sufficiently corrected with clotting factors or fresh frozen plasma (FFP); * Use of anticoagulants that cannot be discontinued; * International normalized ratio (INR) \>1.5 or platelet count \<50,000; * Pregnancy or lactation; * Inability to sign informed consent; * Other concomitant neoplastic diseases.
Where this trial is running
Rome, Roma
- Serena Stigliano — Rome, Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Francesco M Di Matteo
- Email: f.dimatteo@policlinicocampus.it
- Phone: 06225411657
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.