Using Radiogenomics to Noninvasively Predict the Malignant Potential of Intraductal Papillary Mucinous Neoplasms (IPMNs) of the Pancreas and Uncover Hidden Biology
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Cancer
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 1174
- Locations
- 3
- Primary Endpoint
- Predictive value of CT Radiomic features vs conventional radiologic features
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
The Florida Pancreas Collaborative wants to partner with individuals who are known to have, or are suspected to have a pancreatic lesion, tumor, cyst, mass, cancer, or pancreatitis and are undergoing diagnosis and treatment at a participating institution. The goals of this project are to build a large database of information obtained from blood, tissue, medical images, surveys and information from routine care to develop noninvasive diagnostic approaches that could be used as decision-making tools to effectively personalize clinical care.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Individuals who present to the GI clinic, surgery, or endoscopy at Moffitt, Florida Research Institute (FRI), or UM with a clinical suspicion for (or diagnosis of) a pancreatic lesion, cyst, mass, cancer, or pancreatitis based on symptoms, imaging, or blood-work and has not had any treatment involving their pancreas.
- •Able to understand and voluntarily sign the informed consent.
- •Willing to complete study questionnaire(s) and donate medical images and/or biological specimens (including blood, cystic fluid, and/or tissue) obtained at the time of standard of care procedures (biopsy, surgery, and venipuncture) after signing the informed consent document
Exclusion Criteria
- •No suspicion or diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis.
- •Has a diagnosis of a pancreatic lesion, cyst, mass, cancer, or pancreatitis and has already undergone treatment involving the pancreas (which may involve surgery, chemo- or immuno-therapy, and/or radiation).
- •Unable to provide informed consent.
- •Unwilling to complete study questionnaire(s) and/or donate biological specimens or images.
Outcomes
Primary Outcomes
Predictive value of CT Radiomic features vs conventional radiologic features
Time Frame: Up to 2 years
Preoperative CT images will be evaluated for a retrospective cohort of at least 254 pathologically-confirmed IPMN cases (approximately 190 malignant characterized by high-grade dysplasia or invasion and approximately 64 benign characterized by low- or moderate-grade dysplasia). 3D-radiomic features will be extracted with the new Quantitative Imaging Decision Support (QIDS)™ platform (Healthmyne, Inc.) and associations will be evaluated with pathology.
Radiogenomic Analyses
Time Frame: Up to 2 years
Investigators will conduct the first radiogenomic analyses of IPMNs by evaluating the relationship between radiomic features and tissue and circulating levels of candidate biomarkers.
Development of Clinical Decision Making Models for Predicting IPMN Pathology
Time Frame: Up to 2 years
Investigators will develop the first prototype preoperative 'omics'-based nomograms to predict IPMN pathology by integrating radiomic features, the MGC, and other covariates. Emphasis will be placed on developing nomograms for individuals whose IPMNs appear to have 'worrisome' radiologic features which are very challenging to manage.
Secondary Outcomes
- Overall Survival(Up to 4 years)
- Progression Free Survival(Up to 4 years)