Trial Outcomes & Findings for Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging (NCT NCT01815333)

Last Updated: 2020-10-19

Results Overview

Signal intensity (SI) change of a lymph node between the pre- and post- contrast images observed subjectively at each time point. The degree of SI change at each time point compared each other subjectively and a time point showing the nodes best (greatest signal loss relative to that on pre-contrast images) identified (optimum scan time).

Recruitment status

COMPLETED

Study phase

Target enrollment

10 participants

Primary outcome timeframe

3 days

Results posted on

2020-10-19

Participant Flow

Recruitment Period: July 2013 to July 2019. Recruitment took place at the University of Texas MD Anderson Cancer Center.

Participant milestones

Participant milestones
Measure	Feraheme Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational. Feraheme: 6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI. Magnetic Resonance Imaging (MRI): MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day.
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Feraheme n=10 Participants Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational. Feraheme: 6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI. Magnetic Resonance Imaging (MRI): MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day.
Age, Categorical <=18 years	0 Participants n=39 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=39 Participants
Age, Categorical >=65 years	4 Participants n=39 Participants
Sex: Female, Male Female	2 Participants n=39 Participants
Sex: Female, Male Male	8 Participants n=39 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=39 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=39 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=39 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=39 Participants
Race (NIH/OMB) Asian	0 Participants n=39 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=39 Participants
Race (NIH/OMB) Black or African American	0 Participants n=39 Participants
Race (NIH/OMB) White	6 Participants n=39 Participants
Race (NIH/OMB) More than one race	0 Participants n=39 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=39 Participants
Region of Enrollment United States	10 Participants n=39 Participants

PRIMARY outcome

Timeframe: 3 days

Outcome measures

Outcome measures
Measure	Feraheme n=10 Participants Magnetic resonance imaging (MRI) acquired prior to the injection of Feraheme® and repeated at approximately 48 hours and 72 hours from the time of injection (scan time). The scan time will be adjusted, as needed. The MRI scan prior to the Feraheme injection is the routine scan. The scans at 48 and 72 hours are investigational. Feraheme: 6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI. Magnetic Resonance Imaging (MRI): MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day.
Number of Participants With Signal Intensity (SI) Change of a Lymph Node Between the Pre- and Post- Contrast of the Feraheme Enhanced Magnetic Resonance Imaging (MRI)	0 Participants

Adverse Events

Feraheme

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, Abdominal Imaging Department

UT MD Anderson Cancer Center

Phone: 713-745-4693

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place