Detecting subepithelial gastrointestinal tumors using advanced imaging techniques
EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study
Fondazione del Piemonte per l'Oncologia · NCT06324032
This study is testing whether a new imaging technique can help doctors better identify certain types of gastrointestinal tumors in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 138 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Fondazione del Piemonte per l'Oncologia (other) |
| Locations | 7 sites (Imola, Bologna and 6 other locations) |
| Trial ID | NCT06324032 on ClinicalTrials.gov |
What this trial studies
This observational multicenter study aims to evaluate the effectiveness of Endoscopic Ultrasound Elastography (EUS-E) in differentiating subepithelial gastrointestinal tumors (SETs) in 138 patients. Conducted in various Italian hospitals, the study will enroll patients diagnosed with GI SETs by experienced endoscopists. Participants will undergo EUS-E and Contrast-Enhanced Ultrasound (CEUS) procedures, with a diagnostic hypothesis formulated based on the imaging characteristics observed. The study adheres to ethical guidelines and requires informed consent from all participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 85 with gastrointestinal SETs scheduled for EUS-Fine Needle Biopsy (FNB).
Not a fit: Patients with SETs smaller than 15mm or those with severe coagulopathy, cardiopulmonary diseases, chronic kidney disease, known allergies to SonoVue®, or who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of diagnosing subepithelial gastrointestinal tumors, leading to better patient management.
How similar studies have performed: While this approach is being explored, similar studies have shown promise in using EUS techniques for tumor characterization, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with GI SETs scheduled for EUS-FNB 2 Patients with age \> 18 but \<85 Exclusion Criteria: 1. Patients with GI SETs \<15mm 2. severe coagulopathy defined as abnormal prothrombin time (PT) or partial thromboplastin time (PTT) that does not normalize after administration of fresh frozen plasma 3. severe cardiopulmonary diseases and severe chronic kidney disease defined as 4. known allergic disposition to SonoVue® 5. pregnancy
Where this trial is running
Imola, Bologna and 6 other locations
- Ospedale Santa Maria della Scaletta — Imola, Bologna, Italy (RECRUITING)
- Istituto Clinico Humanitas — Rozzano, Milano, Italy (RECRUITING)
- Fondazione del Piemonte per l'Oncologia-IRCCS Candiolo — Candiolo, Turin,, Italy (RECRUITING)
- Ospedale Humanitas Mater Domini — Castellanza, Varese, Italy (RECRUITING)
- AOU Maggiore della Carità — Novara, Italy (RECRUITING)
- Istituto Oncologico Veneto — Padova, Italy (RECRUITING)
- AOU Città della Salute e della Scienza di Torino, Ospedale Molinette — Turin, Italy (RECRUITING)
Study contacts
- Principal investigator: Teresa Staiano, MD — FPO-IRCCS di Candiolo
- Study coordinator: Cristiana Laudi, MD
- Email: Cristiana.laudi@ircc.it
- Phone: +390119933413
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: Subepithelial Gastrointestinal Tumors, subepithelial gastrointestinal tumors, Endoscopic Ultrasound, EUS, SETs, EUS Elastography, surgical resection, histopatological specimens