Pancreatic Cancer
Conditions
Keywords
SPIO MRI, Feridex
Brief 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.
Detailed description
* On the first day, study participants will undergo 2 MRI examinations. A scan will be done prior to administration of the contrast agent (Feraheme) and then a second scan immediately after administration. On the second day, study participants will be asked to return for a third MRI. * All MRI scans will be done at Massachusetts General Hospital.
Interventions
DRUGSuperparamagnetic Iron Oxide Magnetic Resonance Imaging
Two MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol
Sponsors
Massachusetts General Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. | 3 years | Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive. |
| To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. | 3 years | Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SPIO MRI Superparamagnetic Iron Oxide Magnetic Resonance Imaging: Three MRIs will be performed over a two day period. The second scan will be done 48 hours after intravenous infusion of ferumoxytol | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | SPIO MRI |
|---|---|
| Age, Continuous | 64.8 years STANDARD_DEVIATION 13.04 |
| Region of Enrollment United States | 15 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
Primary
To Determine the Sensitivity High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.
Using Pathology as the gold standard the excised nodes were correlated and the percentage of positive cases were measured on the post contrast exam. Sensitivity is the percentage of positive cases (i.e., metastases confirmed using pathology) identified as positive.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPIO MRI | 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 |
Primary
To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases.
Using Pathology as the gold standard the excised nodes were correlated and the percentage of true negative nodes were measured on the post contrast exam. Specificity is the percentage of true negative cases as identified as negative.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPIO MRI | To Determine the Specificity of High Resolution Magnetic Resonance Imaging With Lymphotrophic Superparamagnetic Nanoparticles to Identify Small and Otherwise Undetectable Lymph Node Metastases. | 80 Percentage of true negative sample |