Prostate CancerPhase 1NCT01296139
Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer
A Phase 1 study testing Ferumoxytol in people with Prostate Cancer, run by National Cancer Institute (NCI) at 1 site in United States.
Trial summary
Background: Ferumoxytol is an approved iron replacement therapy agent that has some potential for use as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes that have been affected by cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Ferumoxytol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jan 2011to 19 Mar 2015
- Phase
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be male and be greater than or equal to 18 years old.
- Subject must have a histologically confirmed diagnosis of prostate cancer.
- Subjects enrolling in the lymph node involvement subgroup must have imaging evidence of lymph node involvement (with a size of greater than or equal to 1.5 cm).
- Subject must have Eastern Cooperative Oncology Group Performance score less than or equal to 2.
- Subjects in the dose finding cohorts must be scheduled to undergo prostatectomy for presumed prostate cancer.
- -Subjects must be scheduled to undergo prostatectomy for presumed prostate cancer
- Members of all races and ethnic groups are eligible for this trial.
- Women are excluded from this trial as prostate cancer does not occur in females.
Who cannot join
- Subjects with known hypersensitivity and allergy to iron
- Subjects with evidence of iron overload with a pre-study ferritin level greater than 370 ng/ml and percent saturation of transferrin level greater than 40%. Patients with lab values above these limits may be included in the study if documented hematology consultation rules out hemochromatosis.
- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results
- Subjects with severe claustrophobia unresponsive to oral anxiolytics
- Subjects with contraindications to MRI
- Subjects weighing >136 kg (weight limit for scanner table)
Show all 9Show fewer
- Subjects with pacemakers, cerebral aneurysm clips, shrapnel injury, or other implanted electronic devices or metal not compatible with MRI.
- Subjects with abnormal liver function tests suggesting liver dysfunction (AST and ALT >2 times the upper limits of normal; total bilirubin, of >2 times the upper limits of normal or >3.0 mg/dl in patients with Gilbert s syndrome).
- Subjects with other medical conditions deemed by the principle investigator (or associates) or the sponsor to make the subject ineligible for protocol procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer
Background:
- Ferumoxytol is an approved iron replacement therapy agent that has some potential for use as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes that have been affected by cancer. Ferumoxytol is taken up by normal lymph nodes, but excluded from cancerous lymph node tissue. Because Ferumoxytol has not yet been approved for use as an imaging agent, researchers are interested in testing its effectiveness as a contrast agent for studies of normal lymph tissue and cancer tissue in lymph nodes of individuals with prostate cancer.
Read more
Objectives:
- To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals who are scheduled to have prostate removal surgery to treat prostate cancer.
Eligibility:
- Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have surgery to remove the prostate and surrounding lymph nodes.
Design:
- Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies.
- Participants will have a magnetic resonance imaging (MRI) scan to provide baseline images for the study.
- Participants will receive an injection of Ferumoxytol and will return for another MRI scan on the following day (around 24 hours later).
- Some participants may have a third MRI scan 48 hours after the initial injection of Ferumoxytol. This third MRI scan is optional and not required by the study.
- Although the scanning and followup portion of the study will last only a few days, participants will be considered to be enrolled on the study until after the prostate removal surgery.
Read the detailed description
Background:
- Prostate cancer is the most common non-cutaneous malignancy among men in Western world. Accurate lymph node staging is important in treatment planning for prostate cancer.
- Conventional imaging modalities (e.g. computed tomography [CT] and magnetic resonance imaging [MRI]) are used for the evaluation of lymph node involvement in many cancer types, including prostate cancer, however diagnosis is based on node enlargement which is neither sensitive nor specific in prostate cancer.
- As a consequence, the standard of care is to remove numerous lymph nodes during prostatectomy to ascertain lymph node status.
- A prior imaging agent for detecting lymph node involvement, dextran coated ultrasmall superparamagnetic iron oxide particles (USPIO), also known as Ferumoxtran-10 (Combidex , AMAG Pharmaceuticals, Inc. Lexington, MA, US) was shown to localize lymph node metastases with much greater accuracy than unenhanced MRI. Although a large study in lymph node imaging in prostate cancer was successfully conducted using ferumoxtran-10, the FDA Advisory Panel did not recommend broad use approval of this agent.
- A derivative of ferumoxtran-10, Ferumoxytol (Feraheme AMAG Pharmaceuticals, Inc. Lexington, MA, US) has been approved for iron replacement therapy. It is a semisynthetic carbohydrate coated, magnetic iron oxide preparation. This compound is taken up by normal lymph nodes, excluded from malignant nodal tissue. A single study of Ferumoxytol enhanced MRI demonstrated some efficacy of this agent at 24 hours but only one dose was used, MRI at later time points was not performed.
- Initial results of the NCI trial (11-C-0098) revealed that using the dose of 7.5 mg/kg Fe is safe and it yields a more homogenous and accurate signal changes in benign lymph nodes in comparison with the 4 and 6 mg/kg Fe doses. However, utility of this initial result could not be validated in depiction of signal change difference between benign and malignant lymph nodes with prostate cancer metastases.
Primary Objective
-To determine the optimal dose of Ferumoxytol for enhancing lymph nodes in patients with prostate cancer.
Eligibility
- Subject must be male and be (Bullet)18 years old.
- Subject must have a documented diagnosis of prostate cancer. --Those enrolling in the lymph node involvement subgroup must have imaging evidence of lymph node involvement (with a size of greater than or equal to 1.5cm)
- Eastern Cooperative Oncology Group Performance score of 0 to 2.
- Subjects must be scheduled to undergo prostatectomy and nodal dissection for presumed prostate cancer.
Design:
- Subjects with prostate cancer scheduled for prostatectomy at the NIH Clinical Center will undergo pre-injection, 24, 48 (optional) hours post-Ferumoxytol injection MRI consisting of T1 weighted (W), T2W and T2*W MRI at 3 Tesla magnet.
- In the dose finding cohorts, each dose (4mg/kg Fe, 6mg/kg Fe, 7.5mg/kg Fe) will have an equal number of patients (estimated enrollment will be 5 evaluable patients for each group, making a total of 3x5=15 patients) will be enrolled sequentially. In the lymph node involvement cohort, 5 evaluable subjects will be enrolled.
- Subjects in the dose finding cohorts will undergo clinically indicated prostatectomy, nodal dissection for prostate cancer; histology of resected lymph nodes will be correlated with imaging.
- Subjects in the lymph node involvement cohort may be scheduled to undergo prostatectomy and nodal dissection or core needle biopsy of the lymph node(s) as part of their clinical work-up and histology of resected or biopsied lymph nodes will be correlated with imaging.
- Conditions
- Prostate Cancer
- Being tested
- Ferumoxytol
- Keywords
- Non-Cutaneous Malignancy, Prostatectomy, Metastatic Prostate Cancer, Imaging Study, Magnetic Resonance Imaging, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerumoxytolDrug
All subjects will undergo pre-injection, 24, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) MRI consisting of T1 weighted (W), T2W and T2*W MRI in a 3 Tesla magnet. Additionally, all subjects will undergo pre-injection, 24 hours, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | All subjects will receive 7.5 mg/kg Fe Receives: Drug: Ferumoxytol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal dose of Ferumoxytol for enhancing lymph nodes
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2011 (estimated)
- Study start26 Jan 2011
- Primary completion19 Mar 2015
- Study completion19 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Peter L Choyke, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296139
- Sponsor's protocol ID
- 110098
- Other IDs
- 11-C-0098
- Status last verified
- 19 Mar 2015
- First submitted
- 12 Feb 2011
- Last updated
- 5 Jul 2018
- Results posted
- No
Publications
Li W, Tutton S, Vu AT, Pierchala L, Li BS, Lewis JM, Prasad PV, Edelman RR. First-pass contrast-enhanced magnetic resonance angiography in humans using ferumoxytol, a novel ultrasmall superparamagnetic iron oxide (USPIO)-based blood pool agent. J Magn Reson Imaging. 2005 Jan;21(1):46-52. doi: 10.1002/jmri.20235.
PubMed 15611942Li W, Salanitri J, Tutton S, Dunkle EE, Schneider JR, Caprini JA, Pierchala LN, Jacobs PM, Edelman RR. Lower extremity deep venous thrombosis: evaluation with ferumoxytol-enhanced MR imaging and dual-contrast mechanism--preliminary experience. Radiology. 2007 Mar;242(3):873-81. doi: 10.1148/radiol.2423052101.
PubMed 17325072Neuwelt EA, Varallyay CG, Manninger S, Solymosi D, Haluska M, Hunt MA, Nesbit G, Stevens A, Jerosch-Herold M, Jacobs PM, Hoffman JM. The potential of ferumoxytol nanoparticle magnetic resonance imaging, perfusion, and angiography in central nervous system malignancy: a pilot study. Neurosurgery. 2007 Apr;60(4):601-11; discussion 611-2. doi: 10.1227/01.NEU.0000255350.71700.37.
PubMed 17415196
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ferumoxytol Enhanced MRI for the Detection of Lymph Node Involvement in Prostate Cancer
- ClinicalTrials.gov ID
- NCT01296139
- Acronym / sponsor ID
- 110098
- Conditions
- Prostate Cancer
- Keywords
- Non-Cutaneous Malignancy, Prostatectomy, Metastatic Prostate Cancer, Imaging Study, Magnetic Resonance Imaging, Prostate Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 26 Jan 2011
- Primary completion
- 19 Mar 2015 (actual)
- Study completion
- 19 Mar 2015 (actual)
- First posted
- 15 Feb 2011 (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.
Background:
- Ferumoxytol is an approved iron replacement therapy agent that has some potential for use as a contrast agent in imaging studies of the lymph system, especially involving lymph nodes that have been affected by cancer. Ferumoxytol is taken up by normal lymph nodes, but excluded from cancerous lymph node tissue. Because Ferumoxytol has not yet been approved for use as an imaging agent, researchers are interested in testing its effectiveness as a contrast agent for studies of normal lymph tissue and cancer tissue in lymph nodes of individuals with prostate cancer.
Objectives:
- To evaluate the safety and effectiveness of Ferumoxytol as a contrast agent in individuals who are scheduled to have prostate removal surgery to treat prostate cancer.
Eligibility:
- Men at least 18 years of age who have been diagnosed with prostate cancer and are scheduled to have surgery to remove the prostate and surrounding lymph nodes.
Design:
- Participants will be screened with a full medical history and physical examination, blood and urine tests, and tumor imaging studies.
- Participants will have a magnetic resonance imaging (MRI) scan to provide baseline images for the study.
- Participants will receive an injection of Ferumoxytol and will return for another MRI scan on the following day (around 24 hours later).
- Some participants may have a third MRI scan 48 hours after the initial injection of Ferumoxytol. This third MRI scan is optional and not required by the study.
- Although the scanning and followup portion of the study will last only a few days, participants will be considered to be enrolled on the study until after the prostate removal surgery.
Detailed description
Background:
- Prostate cancer is the most common non-cutaneous malignancy among men in Western world. Accurate lymph node staging is important in treatment planning for prostate cancer.
- Conventional imaging modalities (e.g. computed tomography [CT] and magnetic resonance imaging [MRI]) are used for the evaluation of lymph node involvement in many cancer types, including prostate cancer, however diagnosis is based on node enlargement which is neither sensitive nor specific in prostate cancer.
- As a consequence, the standard of care is to remove numerous lymph nodes during prostatectomy to ascertain lymph node status.
- A prior imaging agent for detecting lymph node involvement, dextran coated ultrasmall superparamagnetic iron oxide particles (USPIO), also known as Ferumoxtran-10 (Combidex , AMAG Pharmaceuticals, Inc. Lexington, MA, US) was shown to localize lymph node metastases with much greater accuracy than unenhanced MRI. Although a large study in lymph node imaging in prostate cancer was successfully conducted using ferumoxtran-10, the FDA Advisory Panel did not recommend broad use approval of this agent.
- A derivative of ferumoxtran-10, Ferumoxytol (Feraheme AMAG Pharmaceuticals, Inc. Lexington, MA, US) has been approved for iron replacement therapy. It is a semisynthetic carbohydrate coated, magnetic iron oxide preparation. This compound is taken up by normal lymph nodes, excluded from malignant nodal tissue. A single study of Ferumoxytol enhanced MRI demonstrated some efficacy of this agent at 24 hours but only one dose was used, MRI at later time points was not performed.
- Initial results of the NCI trial (11-C-0098) revealed that using the dose of 7.5 mg/kg Fe is safe and it yields a more homogenous and accurate signal changes in benign lymph nodes in comparison with the 4 and 6 mg/kg Fe doses. However, utility of this initial result could not be validated in depiction of signal change difference between benign and malignant lymph nodes with prostate cancer metastases.
Primary Objective
-To determine the optimal dose of Ferumoxytol for enhancing lymph nodes in patients with prostate cancer.
Eligibility
- Subject must be male and be (Bullet)18 years old.
- Subject must have a documented diagnosis of prostate cancer. --Those enrolling in the lymph node involvement subgroup must have imaging evidence of lymph node involvement (with a size of greater than or equal to 1.5cm)
- Eastern Cooperative Oncology Group Performance score of 0 to 2.
- Subjects must be scheduled to undergo prostatectomy and nodal dissection for presumed prostate cancer.
Design:
- Subjects with prostate cancer scheduled for prostatectomy at the NIH Clinical Center will undergo pre-injection, 24, 48 (optional) hours post-Ferumoxytol injection MRI consisting of T1 weighted (W), T2W and T2*W MRI at 3 Tesla magnet.
- In the dose finding cohorts, each dose (4mg/kg Fe, 6mg/kg Fe, 7.5mg/kg Fe) will have an equal number of patients (estimated enrollment will be 5 evaluable patients for each group, making a total of 3x5=15 patients) will be enrolled sequentially. In the lymph node involvement cohort, 5 evaluable subjects will be enrolled.
- Subjects in the dose finding cohorts will undergo clinically indicated prostatectomy, nodal dissection for prostate cancer; histology of resected lymph nodes will be correlated with imaging.
- Subjects in the lymph node involvement cohort may be scheduled to undergo prostatectomy and nodal dissection or core needle biopsy of the lymph node(s) as part of their clinical work-up and histology of resected or biopsied lymph nodes will be correlated with imaging.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: FerumoxytolAll subjects will receive 7.5 mg/kg Fe |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject must be male and be greater than or equal to 18 years old.
- Subject must have a histologically confirmed diagnosis of prostate cancer.
- Subjects enrolling in the lymph node involvement subgroup must have imaging evidence of lymph node involvement (with a size of greater than or equal to 1.5 cm).
- Subject must have Eastern Cooperative Oncology Group Performance score less than or equal to 2.
- Subjects in the dose finding cohorts must be scheduled to undergo prostatectomy for presumed prostate cancer.
Key exclusion criteria (9 listed)
- Subjects with known hypersensitivity and allergy to iron
- Subjects with evidence of iron overload with a pre-study ferritin level greater than 370 ng/ml and percent saturation of transferrin level greater than 40%. Patients with lab values above these limits may be included in the study if documented hematology consultation rules out hemochromatosis.
- Subjects with any coexisting medical or psychiatric condition that is likely to interfere with study procedures and/or results
- Subjects with severe claustrophobia unresponsive to oral anxiolytics
- Subjects with contraindications to MRI
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 |
|---|---|---|
| FerumoxytolAll subjects will undergo pre-injection, 24, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) MRI consisting of T1 weighted (W), T2W and T2*W MRI in a 3 Tesla magnet. Additionally, all subjects will undergo pre-injection, 24 hours, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) ultrasound. | Drug | A |
Primary outcome
Optimal dose of Ferumoxytol for enhancing lymph nodes
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Background: PubMed 15611942Li W, Tutton S, Vu AT, Pierchala L, Li BS, Lewis JM, Prasad PV, Edelman RR. First-pass contrast-enhanced magnetic resonance angiography in humans using ferumoxytol, a novel ultrasmall superparamagnetic iron oxide (USPIO)-based blood pool agent. J Magn Reson Imaging. 2005 Jan;21(1):46-52. doi: 10.1002/jmri.20235.
- Background: PubMed 17325072Li W, Salanitri J, Tutton S, Dunkle EE, Schneider JR, Caprini JA, Pierchala LN, Jacobs PM, Edelman RR. Lower extremity deep venous thrombosis: evaluation with ferumoxytol-enhanced MR imaging and dual-contrast mechanism--preliminary experience. Radiology. 2007 Mar;242(3):873-81. doi: 10.1148/radiol.2423052101.
- Background: PubMed 17415196Neuwelt EA, Varallyay CG, Manninger S, Solymosi D, Haluska M, Hunt MA, Nesbit G, Stevens A, Jerosch-Herold M, Jacobs PM, Hoffman JM. The potential of ferumoxytol nanoparticle magnetic resonance imaging, perfusion, and angiography in central nervous system malignancy: a pilot study. Neurosurgery. 2007 Apr;60(4):601-11; discussion 611-2. doi: 10.1227/01.NEU.0000255350.71700.37.
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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.
Peter L Choyke, M.D. principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ferumoxytol in people with Prostate Cancer, run by National Cancer Institute (NCI) 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 8 inclusion and 9 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: finished, as of the sponsor's last update on 5 Jul 2018. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Optimal dose of Ferumoxytol for enhancing lymph nodes (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296139, which also lists 3 linked publications.
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 5 Jul 2018.