Status:
TERMINATED
Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Head and Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
The goal of this clinical research study is to learn if ferumoxytol, when given at the time of a magnetic resonance imaging (MRI), can help researchers learn more about the spread of certain kinds of ...
Detailed Description
Study Scans: If you are found to be eligible to take part in this study, you will have 2 study MRIs. These scans will be performed at the Center for Advanced Biomedical Imaging (CABI), in the South C...
Eligibility Criteria
Inclusion
- Patients 18 years of age or older with histologically or cytologically confirmed head and neck squamous cell carcinoma or melanoma
- Measurable clinical and/or radiographic poly-nodal disease defined as stage N2b, N2c or N3 disease with multiple involved lymph nodes as defined by the American Joint Committee on Cancer (AJCC) cancer staging criteria
- Patients who have received or are dispositioned to receive a Positron emission tomography (PET) and computerized tomography (CT) \[PET-CT\] scan within two weeks of starting definitive therapy for their head and neck malignancy and their participation in this study. This implies patients must receive a PET-CT to be eligible for the study.
Exclusion
- Patients who have undergone definitive resection of their primary or nodal disease as well as any chemotherapy or radiation therapy for their head and neck primary tumor.
- Patients unable or unwilling to give written, informed consent or to undergo MRI imaging.
- Women of childbearing potential (A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months \[i.e., who has had menses at any time in the preceding 24 consecutive months\]). Male partners must practice effective contraception (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) throughout the study.
- Patients unable to tolerate DCE-MRI or having an estimated GFR \< 60 ml/min/1.73m\^2.
- Contraindications to iron supplementation include hemochromatosis, colitis, history of GI bleeds, alcoholism, or liver disease. Ferumoxytol is contraindicated in patients with evidence of iron overload and/or known hypersensitivity to Feraheme or any of its components. Consequently, we will plan to exclude patients who have symptoms or signs that might be caused by iron overload. These include patients with (unexplained): arthritis (including premature osteoarthritis), congestive heart failure or cardiomyopathy, adult-onset diabetes, secondary hypogonadism, increased skin pigmentation, or patients with persistently elevated serum ferritin not explained by an underlying inflammatory/systemic disease, unless these patients demonstrate a fasting transferrin saturation \</= 0.45.
- Patients with any evidence of iron overload on pre-imaging laboratory studies.
- Patients with any contraindications to gadolinium-based contrast agents.
- Patients with claustrophobia.
Key Trial Info
Start Date :
September 12 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2021
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01895829
Start Date
September 12 2013
End Date
September 7 2021
Last Update
September 21 2021
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030