Phase 4
Completed N=15
Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)
Source: ClinicalTrials.gov NCT00920023 ↗Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. — 83.3 percentage of positive cases
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this research study is to see if a specific kind of MRI, called Ultrasmall Superparamagnetic Iron Oxide Magnetic Resonance Imaging (USPIO MRI), which uses an FDA-approved therapeutic agent(Feraheme) to see if it is able to identify small and otherwise undetectable lymph node metastases in people who have pancreatic cancer and are scheduled for surgical resection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. |
83.3 | — |
| PRIMARY To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. |
80 | — |
Eligibility Criteria
Inclusion Criteria
- Locally resectable pancreatic mass present on one or more pre-operative imaging modalities
- Must demonstrate no evidence of distant metastases as assessed by chest/abdomen/pelvis CT scan
- Deemed eligible for resection with curative intent by a treating surgeon who is listed as an investigator on this study
- 18 years of age or older
- No uncontrolled serious medical or psychiatric illness
- Women of childbearing potential must not be pregnant or lactating
Exclusion Criteria
- Known allergy to iron or dextran
- Pregnant or lactating
- Counter-indication to MRI, such as the presence of metallic prostheses or implanted metal device
- Sickle cell disease or hemoglobinopathy
Data sourced from ClinicalTrials.gov (NCT00920023). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.