Trial Outcomes & Findings for Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI) (NCT NCT00920023)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

35 participants

Primary outcome timeframe

3 years

Results posted on

2017-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pre-Operative Staging of Pancreatic Cancer Using Superparamagnetic Iron Oxide Magnetic Resonance Imaging (SPIO MRI)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	SPIO MRI n=15 Participants 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
Age, Continuous	64.8 years STANDARD_DEVIATION 13.04 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Region of Enrollment United States	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SPIO MRI n=15 Participants 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
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 Interval 36.4 to 99.1

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	SPIO MRI n=15 Participants 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
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 Interval 29.8 to 98.9

Adverse Events

SPIO MRI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ralph Weissleder

Massachusetts General Hospital

Phone: 6177268226

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place