Trial Outcomes & Findings for A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast (NCT NCT00147238)

Results Overview

Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI

Results posted on

2012-08-07

Participant Flow

Recruitment Period: 08/24/05 through 06/12/06. All participants recruited at UT MD Anderson Cancer Center.

A total of 10 patients enrolled prior to sponsor's request for early termination. Only 2 patients were evaluable for response therefore data will not be analyzed due to too small sample size.

Participant milestones

Participant milestones
Measure	Ferumoxtran-10 MRI Contrast Agent
Overall Study STARTED	10
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Reasons for withdrawal
Measure	Ferumoxtran-10 MRI Contrast Agent
Overall Study Inevaluable	8

Baseline Characteristics

A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ferumoxtran-10 MRI Contrast Agent n=10 Participants
Age Continuous	64 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	10 participants n=5 Participants

PRIMARY outcome

Timeframe: MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI

Population: Primary outcome measure was not assessed due to early study termination (e.g. patients did not receive assigned treatment).

Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high).

Outcome measures

Outcome data not reported

Adverse Events

Ferumoxtran-10 MRI Contrast Agent

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

Haesun Choi, MD / Professor

UT MD Anderson Cancer Center

Phone: 713-745-4693

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place