Comparing 3D imaging to CT for assessing pancreatic cancer treatment response
Is 3-D Imaging Technology Superior to Computed Tomography in Assessing Response to Neoadjuvant Treatment in Patients With Borderline or Locally Advanced Pancreatic Adenocarcinoma?
This study is testing if a new 3D imaging method is better than regular CT scans at showing how well chemotherapy is working for patients with certain types of pancreatic cancer before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 70 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación para la Investigación del Hospital Clínico de Valencia Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 17 sites (Alicante and 16 other locations) |
| Trial ID | NCT06582342 on ClinicalTrials.gov |
What this trial studies
This prospective multicenter study aims to evaluate the effectiveness of 3D-MSP imaging technology compared to traditional CT scans in assessing the response of patients with borderline or locally advanced pancreatic adenocarcinoma to neoadjuvant chemotherapy. Patients will undergo both imaging techniques prior to surgical exploration, allowing for a direct comparison of their accuracy in predicting surgical outcomes. The study will analyze various accuracy metrics, including sensitivity and specificity, against the gold standard of surgical and histopathological results. By utilizing a within-patient control design, each participant serves as their own control, enhancing the reliability of the findings.
Who should consider this trial
Good fit: Ideal candidates are adults diagnosed with borderline or locally advanced pancreatic adenocarcinoma who have received neoadjuvant chemotherapy and are scheduled for surgical exploration.
Not a fit: Patients who are younger than 18 years, have experienced disease progression during treatment, or have not undergone a preoperative CT scan will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of preoperative assessments, potentially leading to better surgical outcomes for patients with pancreatic cancer.
How similar studies have performed: While the use of advanced imaging technologies is gaining traction, this study represents a novel approach as there are currently no prospective validation studies specifically comparing 3D-MSP technology to CT in this patient population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- Patients with a diagnosis of borderline or locally advanced PAC of the head of the pancreas, as defined by the National Comprehensive Cancer Network (NCCN), who have received neoadjuvant treatment and who undergo surgical exploration with resective intent. Exclusion Criteria: * Patients younger than 18 years of age. * Patients under 18 years of age. * Disease progression during neoadjuvant treatment. * No preoperative CT scan. * Refusal to participate in the study.
Where this trial is running
Alicante and 16 other locations
- Hospital General de Alicante — Alicante, Spain (Recruiting)
- Hospital Universitario de Badajoz — Badajoz, Spain (Recruiting)
- Hospital del Mar (Barcelona) — Barcelona, Spain (Recruiting)
- Hospital Clínic de Barcelona — Barcelona, Spain (Recruiting)
- Hospital de Bellvitge — Barcelona, Spain (Recruiting)
- Hospital German Trias y Puyol — Barcelona, Spain (Recruiting)
- Hospital Nuestra señora de la Candelaria — Candelaria, Spain (Recruiting)
- Hospital General de Castellón — Castellon, Spain (Recruiting)
- Hospital Carlos Haya — Málaga, Spain (Recruiting)
- Hospital Virgen de la Victoria — Málaga, Spain (Recruiting)
- Hospital Virgen de la Arrixaca — Murcia, Spain (Recruiting)
- Hospital Son Espases Palma de Mallorca — Palma de Mallorca, Spain (Recruiting)
- Hospital Virgen del Rocío — Seville, Spain (Recruiting)
- Hospital Juan XXIII Tarragona — Tarragona, Spain (Recruiting)
- Hospital Clínico Universitario de Valencia — Valencia, Spain (Recruiting)
- Hospital Dr Peset — Valencia, Spain (Recruiting)
- Hospital La Fe — Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Dimitri Dorcaratto
- Email: dorcaratto.dimitri@gmail.com
- Phone: 675441388
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.