Evaluating FDG PET-MRI-based Biomarkers in Borderline Resectable Pancreatic Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-010545
Sponsor Protocol Number: 16-010545
About this study
Aims, purpose, or objectives:
- Evaluation of quantitative biomarkers derived from simultaneous time-of-flight FDG PET-MRI/MRCP for assessment of response to neoadjuvant therapy in borderline resectable PDAC.
- Evaluate the comparative performance of blood and FDG PET-MRI/MRCP based biomarkers for assessment of response to neoadjuvant therapy in borderline resectable PDAC.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Subject population (children, adults, groups): Subjects, age greater than 18, with borderline resectable pancreatic cancer undergoing clinically scheduled FDG PET-MRI/MRCP examinations.
Inclusion Criteria:
- Treatment-naïve patients with tumor anatomy consistent with borderline resectable PDAC on comprehensive staging evaluation.
- No known distant metastatic disease at initial staging.
- Patients who are deemed candidates for neo-adjuvant therapy and are going to have clinically indicated FDG-PET-MRI examination, before and after the neo-adjuvant therapy.
Exclusion Criteria:
- Prior resection for PDAC
- History of other malignancy less than or equal to 5 years previously.
- Patients who are deemed not suitable for curative resection after neo-adjuvant therapy.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Ajit Goenka, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available