Clinical and Technical Feasibility of a Ultrasuperparamagnetic Nanoparticle Iron Oxide (USPIO)-Enhanced Magnetic Resonance Lymph Node Imaging
Study Details
Study Description
Brief Summary
The goal of this clinical research study is to learn if the drug Feraheme ® (ferumoxytole) helps researchers most clearly to "see" cancerous lymph nodes on an MRI scan. Researchers also want to learn if ferumoxytole may be used in liver imaging.
Ferumoxytole is designed to deliver iron to treat iron-deficiency anemia (low red blood cell counts) in patients with chronic kidney disease. In this study, it will be used as an MRI contrast. Contrasts are used by doctors in order to see MRI images more clearly.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Study Participation:
If you are found to be eligible, during the following MRI scans, you will pass into a long, narrow tube scanner, which is open at both ends. You will have a total of 3 MRI scans.
You will have an MRI scan before you receive ferumoxytole as needed. This is the standard-of-care MRI scan. You will then receive ferumoxytole by vein. If you are scheduled to have an MRI scan of your abdomen, or if you have visible lymph nodes in the abdomen, you will stay in the MRI scanner an extra 30 minutes for liver imaging right after you receive your dose of ferumoxytole. This is a part of an investigational scan (Visit 1--Day 1)
You will then return for an MRI scan 2 days later (Visit 2--Day 2) and then again the following day (Visit 3--Day 3) to scan your lymph nodes. These are the investigational scans. The timing of the second and third scans may be changed based on the study doctor's decision.
Length of Study:
Your participation on this study will be over after the third MRI scan.
Additional Information:
The images collected as part of this study will not be included as part of your medical record. If any of the images and/or information from this study are used for publication, all identifiable information will be removed. The data will be stored for 5 years after the study data has been published.
This is an investigational study. Ferumoxytole is FDA approved and commercially available for the treatment of iron-deficiency anemia in patients with chronic kidney disease. Its use to help researchers "see" cancerous lymph nodes from an MRI scan is considered investigational.
Up to 18 participants will be enrolled in this study. All will take part at MD Anderson.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Drug: 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.
Other Names:
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- 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) [3 days]
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).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Enrolled at MDACC, Written consent
-
Measurable nodes on the recent cross sectional imaging (CT, MRI. US) or suspicious lymph nodes for metastasis
-
Requiring tissue diagnosis (FNA, core biopsy, surgical biopsy, surgical resection), or clinical follow-ups for at least 6 months.
-
Any and all primary disease sites in the abdomen and pelvis will be allowed
Exclusion Criteria:
-
Primary or secondary iron overload
-
Lactation or pregnant - women of child bearing potential will be excluded
-
Contraindications for MRI
-
Contraindication or allergy to Feraheme® (based on insert)
-
Clinically documented or risk of primary or secondary iron overloading (e.g. History of thalassemia, sickle cell anemia, hereditary hemochromatosis, multiple transfusions with any reason), anemia not caused by iron deficiency
-
Age under 18
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Texas MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- M.D. Anderson Cancer Center
Investigators
- Principal Investigator: Haesun Choi, MD, M.D. Anderson Cancer Center
Study Documents (Full-Text)
More Information
Additional Information:
Publications
None provided.- 2012-0926
- NCI-2014-02435
Study Results
Participant Flow
| Recruitment Details | Recruitment Period: July 2013 to July 2019. Recruitment took place at the University of Texas MD Anderson Cancer Center. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Feraheme |
|---|---|
| Arm/Group Description | 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. |
| Period Title: Overall Study | |
| STARTED | 10 |
| COMPLETED | 10 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | Feraheme |
|---|---|
| Arm/Group Description | 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 Participants | 10 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
6
60%
|
| >=65 years |
4
40%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
2
20%
|
| Male |
8
80%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
1
10%
|
| Not Hispanic or Latino |
8
80%
|
| Unknown or Not Reported |
1
10%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
1
10%
|
| Black or African American |
0
0%
|
| White |
6
60%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
3
30%
|
| Region of Enrollment (Count of Participants) | |
| United States |
10
100%
|
Outcome Measures
| Title | 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) |
|---|---|
| Description | 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). |
| Time Frame | 3 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Feraheme |
|---|---|
| Arm/Group Description | 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. |
| Measure Participants | 10 |
| Count of Participants [Participants] |
0
0%
|
Adverse Events
| Time Frame | from injection, over the course of scanning, up to 3 days | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Feraheme | |
| Arm/Group Description | 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. | |
All Cause Mortality |
||
| Feraheme | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Serious Adverse Events |
||
| Feraheme | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Feraheme | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Haesun Choi, MD/ Professor, Abdominal Imaging Department |
|---|---|
| Organization | UT MD Anderson Cancer Center |
| Phone | 713-745-4693 |
| hchoi@mdanderson.org |
- 2012-0926
- NCI-2014-02435