Head and Neck CancerEarly Phase 1NCT01895829
Ferumoxytol - Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI
A Early Phase 1 study testing Magnetic Resonance Imaging (MRI) and Ferumoxytol in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Magnetic Resonance Imaging (MRI) and Ferumoxytol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2013to 7 Sep 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Pilot Feasibility Study of Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI for Primary and Nodal Tumor Imaging in Locally Advanced Head and Neck Squamous Cell Carcinomas
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.
Read the 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 Campus Research Building at MD Anderson.
On Day 1, you will have 2 standard MRIs, as part of your standard of care. About an hour after these 2 scans, you will receive ferumoxytol by vein. Right after that, you will have your first study MRI. The study MRI will be performed in the same way that a standard MRI is performed.
On Day 2, about 24 and 72 hours after you receive ferumoxytol, you will have a second study MRI.
Additional Tests:
On Days 1 and 3, as well as 4 weeks after the first study MRI:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests and/or to check your iron level.
On Day 2:
- You will have a physical exam.
- If you have not had one in the last month, you will have a PET-CT scan to check the status of the disease.
Length of Study:
You will be on study for about 4 weeks. You will be taken off study if you have intolerable side effects or you are unable to have the scans for any reason.
This is an investigational study. Ferumoxytol is commercially available and FDA-approved for the treatment of iron deficiency anemia.
Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.
- Conditions
- Head and Neck Cancer
- Being tested
- Magnetic Resonance Imaging (MRI), Ferumoxytol
- 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
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance Imaging (MRI)Procedure or surgery
Also called MRI
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.
FerumoxytolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Magnetic Resonance Imaging (MRI); Drug: Ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2013 (estimated)
- Study start12 Sep 2013
- Primary completion7 Sep 2021
- Study completion7 Sep 2021
Why it stopped: Study halted prematurely and will not resume
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clifton Fuller, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01895829
- Sponsor's protocol ID
- 2012-1127
- Other IDs
- NCI-2013-02182
- Status last verified
- Sep 2021
- First submitted
- 3 Jul 2013
- Last updated
- 21 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Feasibility Study of Iron Oxide Nanoparticle Magnetic Resonance Dynamic Contrast Enhanced MRI for Primary and Nodal Tumor Imaging in Locally Advanced Head and Neck Squamous Cell Carcinomas
- ClinicalTrials.gov ID
- NCT01895829
- Acronym / sponsor ID
- 2012-1127
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted prematurely and will not resume
- Enrolment
- 7 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 12 Sep 2013 (actual)
- Primary completion
- 7 Sep 2021 (actual)
- Study completion
- 7 Sep 2021 (actual)
- First posted
- 11 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Campus Research Building at MD Anderson.
On Day 1, you will have 2 standard MRIs, as part of your standard of care. About an hour after these 2 scans, you will receive ferumoxytol by vein. Right after that, you will have your first study MRI. The study MRI will be performed in the same way that a standard MRI is performed.
On Day 2, about 24 and 72 hours after you receive ferumoxytol, you will have a second study MRI.
Additional Tests:
On Days 1 and 3, as well as 4 weeks after the first study MRI:
- You will have a physical exam.
- Blood (about 2 teaspoons) will be drawn for routine tests and/or to check your iron level.
On Day 2:
- You will have a physical exam.
- If you have not had one in the last month, you will have a PET-CT scan to check the status of the disease.
Length of Study:
You will be on study for about 4 weeks. You will be taken off study if you have intolerable side effects or you are unable to have the scans for any reason.
This is an investigational study. Ferumoxytol is commercially available and FDA-approved for the treatment of iron deficiency anemia.
Up to 20 patients will take part in this study. All will be enrolled at MD Anderson.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ferumoxytol + Magnetic Resonance Imaging (MRI) | Experimental | Procedure: Magnetic Resonance Imaging (MRI), Drug: FerumoxytolOn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance Imaging (MRI)Also: MRIOn 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. | Procedure or surgery | Ferumoxytol + Magnetic Resonance Imaging (MRI) |
| FerumoxytolOn 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. | Drug | Ferumoxytol + Magnetic Resonance Imaging (MRI) |
Primary outcome
Feasibility of Using Ferumoxytol with Magnetic Resonance Imaging (MRI)
Time frame: 2 days
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.
Results and safety
The study was stopped early (reason given: Study halted prematurely and will not resume). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2021.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clifton Fuller, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Magnetic Resonance Imaging (MRI) and Ferumoxytol in people with Head and Neck Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study halted prematurely and will not resume). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Using Ferumoxytol with Magnetic Resonance Imaging (MRI) (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2021.