Biophotonic Nanoparticle-enabled Laser Blood Test for Early Detection of Pancreatic Cancer

NCT07659639 | Recruiting DMC

• 1 other identifier: 67.24CET2CBM
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

LASERBLOOD is based on a biophotonic technology that can be used to predict the development of Pancreatic Ductal Adenocarcinoma (PDAC) in particular categories of subjects at risk (e.g. persons with diabetes, obese people, patients with Intraductal Papillary Mucinous Neoplasm \[IPMN\] or other cystic diseases of the pancreas, etc.) and at the same time offer the possibility of verifying the real effectiveness of the treatments to which affected patients are subjected.

Conditions

Diabetes; IPMN, Pancreatic; PDAC - Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Diagnostic Accuracy of the Biophotonic Nanoparticle-Enabled Laser Blood Test (LASERBLOOD) for Detection of Pancreatic Ductal Adenocarcinoma (PDAC)

  Area Under the Receiver Operating Characteristic Curve (AUC-ROC), with 95% confidence interval, of fluorescence lifetime fingerprints obtained by biophotonic laser analysis of nanoparticle-protein corona complexes in plasma, in discriminating subjects with histologically confirmed Pancreatic Ductal Adenocarcinoma (PDAC) from subjects without PDAC (including healthy controls and patients with Intraductal Papillary Mucinous Neoplasm \[IPMN\]). The reference standard is histopathological diagnosis (on surgical specimen or endoscopic ultrasound-guided fine-needle aspiration/biopsy \[EUS-FNA/B\]) for PDAC and IPMN, and radiological/clinical assessment for healthy controls.

  At baseline (time of enrollment), with reference standard diagnosis confirmed within 12 months

Secondary Outcomes (3)

• Sensitivity and Specificity of Fluorescence Lifetime (FL) Fingerprints for Pancreatic Ductal Adenocarcinoma (PDAC) Detection at Optimal Cut-off

  At baseline (time of enrollment), with reference standard diagnosis confirmed within 12 months

• Correlation Between Fluorescence Lifetime (FL) Fingerprints and Clinical Stage of Pancreatic Ductal Adenocarcinoma (PDAC)

  At time of PDAC diagnosis (within 12 months from enrollment)

• Mean Fluorescence Lifetime (FL) Values of Nanoparticle-Protein Corona Complexes in Plasma Samples, by Diagnostic Group

  At baseline (time of enrollment), prior to any treatment

Study Arms (1)

DIAGNOSTIC

EXPERIMENTAL

Acquisition of biological material for bio-photonic technology analysis

Diagnostic Test: Diagnostic procedures

Interventions

Diagnostic procedures DIAGNOSTIC_TEST

Acquisition of biological material for bio-photonic technology analysis

DIAGNOSTIC

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• No history of prior neoplastic diseases;
• Adequate renal and hepatic function;
• No hematologic disorders;
• Age ≥ 18 years;
• No active infections;
• Written informed consent.

You may not qualify if:

• Severe pre-existing medical conditions, such as serious illnesses or other medical conditions that could negatively affect study outcomes or pose a high risk to the patient's health;
• Ongoing therapies that could interfere with the study or alter the results.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Campus Bio-Medico: lead

Study Sites (1)

Fondazione Policlinico Universitario Campus Bio-Medico

Rome, Italy, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Pancreatic Intraductal Neoplasms

Interventions

Diagnostic Techniques and Procedures

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases

Intervention Hierarchy (Ancestors)

Diagnosis

Central Study Contacts

Damiano Caputo, MD

CONTACT

+3906225418012; d.caputo@policlinicocampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: June 22, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): August 1, 2029
• Last Updated: June 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)