Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI

NCT01895829 | Terminated Early Phase 1 FDA Drug

• 2 other identifiers: 2012-1127NCI-2013-02182
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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 cancers. Ferumoxytol 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.

Conditions

Head and Neck Cancer

Keywords

Head and Neck Cancer; Squamous cell carcinomas of the head and neck; HNSCC; Magnetic resonance imaging; MRI; Ferumoxytol; Ultra-small superparamagnetic iron oxide nanoparticle; USPIO; Contrast agent; Dynamic contrast imaging; DCI

Outcome Measures

Primary Outcomes (1)

• Feasibility of Using Ferumoxytol with Magnetic Resonance Imaging (MRI)

  Feasibility defined as at least 15 (75%) patients finish the imaging process and good quality images obtained. Good quality image defined as subjective quality assessment score of 4 by two independent radiation oncologists and one radiologist for clinical usability for radiotherapy planning on a 5-point scale. The 5-point scale is defined with 0 implying unable to assess and 5 implying optimal image quality.

  2 days

Study Arms (1)

Ferumoxytol + Magnetic Resonance Imaging (MRI)

EXPERIMENTAL

On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein. Right after that, first study MRI performed. The study MRI performed in the same way that a standard MRI is performed. On Day 2, about 24 hours after patient receives ferumoxytol, second study MRI performed.

Procedure: Magnetic Resonance Imaging (MRI); Drug: Ferumoxytol

Interventions

Magnetic Resonance Imaging (MRI) PROCEDURE

On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein. Right after that, first study MRI performed. On Day 2, about 24 hours after patient receives ferumoxytol, second study MRI performed.

Also known as: MRI

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Ferumoxytol DRUG

On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein.

Ferumoxytol + Magnetic Resonance Imaging (MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Magnetic Resonance Spectroscopy; Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals

Study Officials

• Clifton Fuller, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2013
• First Posted: July 11, 2013
• Study Start: September 12, 2013
• Primary Completion: September 7, 2021
• Study Completion: September 7, 2021
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

US (1)