Bladder CancerNCT00147238
A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast
A study testing Ferumoxtran-10 (USPIO) and MR lymphangiography in people with Bladder Cancer and Genitourinary 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 evaluate how well ferumoxtran-10, a new Magnetic Resonance Imaging (MRI) contrast agent, can detect cancer in the pelvic lymph nodes or malignant pelvic lymph nodes. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Bladder Cancer, Genitourinary Cancer, Prostate Cancer
- What is being tested?
- Ferumoxtran-10 (USPIO) and MR lymphangiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2005to Jan 2007
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with newly diagnosed pelvic urological tumors, including prostate carcinomas, bladder carcinomas, and penile carcinomas.
- Planned to have a surgical exploration or a laparoscopy for pelvic lymph node dissection/biopsy within 4 weeks.
- Signed written consent and HIPAA authorization
Who cannot join
- Contraindications for MRI
- Claustrophobia, metals in the pelvis, previous pelvic surgery
- Allergy or hypersensitivity to iron products, dextrans, iron-dextran complex
- a. Prostate cancer: metastases demonstrated on preoperative imaging; prior hormonal therapy greater than 3 months; prior local therapy for prostate cancer b. Penile Cancer: prior systemic therapy for penile cancer; prior inguinal radiation c. Bladder Cancer: prior systemic therapy for bladder cancer (does NOT include intravesical chemotherapy or immunotherapy); prior pelvic radiation; history of partial cystectomy or prior pelvic lymph node dissection
- Women of child-bearing potential. (Women who will be having hysterectomy as part of bladder surgery will not be excluded.)
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
U.T.M.D. Anderson Cancer Center
Houston, Texas, 77030
About this study
The goal of this clinical research study is to evaluate how well ferumoxtran-10, a new Magnetic Resonance Imaging (MRI) contrast agent, can detect cancer in the pelvic lymph nodes or malignant pelvic lymph nodes.
Read the detailed description
The contrast agent, ferumoxtran-10, is made of ultra small iron oxide particles (USPIO). Once they are injected through vein, they are taken up mostly by liver, spleen, bone marrow, and lymph nodes. It takes about 24 - 36 hours to reach peak uptake in the lymph nodes. The ability of current imaging techniques to detect the lymph nodes disease is known to be less than perfect. Current techniques only use anatomic information (size). Previous studies have shown that this new contrast agent may be able to detect normal and abnormal lymph nodes, using MRI procedure, called MRI lymphangiogram. This new contrast agent is being evaluated to determine whether it can be used to detect normal and abnormal lymph nodes.
The study includes 2 parts. The first part will involve you receiving a MRI examination before the contrast is injected. The second part will involve you receiving a MRI examination about 24 hours after the injection. It will take about 20 minutes for each part.
If you are already scheduled to have a routine pelvic MRI, the first part of this study will be added at the end of the routine MRI. You will then be asked to return next day to complete the second part of the MRI. If you are not already scheduled to receive a MRI as part of your standard of care, you will come in to the MRI suite at M. D. Anderson and complete both parts over about a 24-hour interval.
You will be lying on the MRI examination table during the scanning. At the end of the first part of the study, the contrast will be infused slowly through vein over about 30 minutes in the recovery area. You will then be observed for 30 minutes to 2 hours, depending on your tolerance to the contrast agent. The images taken during the first part will be then be repeated 24-36 hours later. You will receive a follow-up telephone call from a member of the study staff on Day 3.
Once the second part of the MRI is performed, your participation in this study will be over.
This is an investigational study. This contrast agent is currently being evaluated by FDA and has not been approved yet. A total of 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Bladder Cancer, Genitourinary Cancer, Prostate Cancer
- Being tested
- Ferumoxtran-10 (USPIO), MR lymphangiography
- Keywords
- Bladder Cancer, Genitourinary Cancer, Prostate Cancer, MR Lymphangiography, Ferumoxtran-10, SPIO, Ultra-small superparamagnetic agent iron oxide
- Medical subject headings
- Urinary Bladder Neoplasms, Urogenital Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferumoxtran-10 (USPIO)Drug
Also called MRI Contrast Agent, Ultra-small superparamagnetic oxide particles
Intravenous infusion of 2.6 mg/kg of ferumoxtran-10
MR lymphangiographyProcedure or surgery
Also called MRI, Magnetic Resonance Imaging
First MRI examination before ferumoxtran-10 contrast injected and second MRI examination about 24 hours after injection of contrast agent, each MRI taking 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ferumoxtran-10 MRI | Experimental | MR lymphangiography using Ferumoxtran-10 contrast agent. Receives: Drug: Ferumoxtran-10 (USPIO); Procedure: MR lymphangiography |
| MRI | Active comparator | MR lymphangiography before injecting Ferumoxtran-10 contrast agent. Receives: Procedure: MR lymphangiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of MRI Per Patient
Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high).
Measured: MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJul 2005
- Primary completionJan 2007
- Study completionJan 2007
Why it stopped: Terminated at request of sponsor.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haesun Choi, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00147238
- Sponsor's protocol ID
- 2004-0003
- Status last verified
- Jul 2012
- First submitted
- 6 Sep 2005
- Last updated
- 7 Aug 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast
- ClinicalTrials.gov ID
- NCT00147238
- Acronym / sponsor ID
- 2004-0003
- Conditions
- Bladder Cancer, Genitourinary Cancer, Prostate Cancer
- Keywords
- Bladder Cancer, Genitourinary Cancer, Prostate Cancer, MR Lymphangiography, Ferumoxtran-10, SPIO, Ultra-small superparamagnetic agent iron oxide
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated at request of sponsor.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Jul 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 7 Sep 2005 (estimated)
- Results
- Posted 27 Jan 2010
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 evaluate how well ferumoxtran-10, a new Magnetic Resonance Imaging (MRI) contrast agent, can detect cancer in the pelvic lymph nodes or malignant pelvic lymph nodes.
Detailed description
The contrast agent, ferumoxtran-10, is made of ultra small iron oxide particles (USPIO). Once they are injected through vein, they are taken up mostly by liver, spleen, bone marrow, and lymph nodes. It takes about 24 - 36 hours to reach peak uptake in the lymph nodes. The ability of current imaging techniques to detect the lymph nodes disease is known to be less than perfect. Current techniques only use anatomic information (size). Previous studies have shown that this new contrast agent may be able to detect normal and abnormal lymph nodes, using MRI procedure, called MRI lymphangiogram. This new contrast agent is being evaluated to determine whether it can be used to detect normal and abnormal lymph nodes.
The study includes 2 parts. The first part will involve you receiving a MRI examination before the contrast is injected. The second part will involve you receiving a MRI examination about 24 hours after the injection. It will take about 20 minutes for each part.
If you are already scheduled to have a routine pelvic MRI, the first part of this study will be added at the end of the routine MRI. You will then be asked to return next day to complete the second part of the MRI. If you are not already scheduled to receive a MRI as part of your standard of care, you will come in to the MRI suite at M. D. Anderson and complete both parts over about a 24-hour interval.
You will be lying on the MRI examination table during the scanning. At the end of the first part of the study, the contrast will be infused slowly through vein over about 30 minutes in the recovery area. You will then be observed for 30 minutes to 2 hours, depending on your tolerance to the contrast agent. The images taken during the first part will be then be repeated 24-36 hours later. You will receive a follow-up telephone call from a member of the study staff on Day 3.
Once the second part of the MRI is performed, your participation in this study will be over.
This is an investigational study. This contrast agent is currently being evaluated by FDA and has not been approved yet. A total of 80 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ferumoxtran-10 MRI | Experimental | Drug: Ferumoxtran-10 (USPIO), Procedure: MR lymphangiographyMR lymphangiography using Ferumoxtran-10 contrast agent. |
| MRI | Active comparator | Procedure: MR lymphangiographyMR lymphangiography before injecting Ferumoxtran-10 contrast agent. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with newly diagnosed pelvic urological tumors, including prostate carcinomas, bladder carcinomas, and penile carcinomas.
- Planned to have a surgical exploration or a laparoscopy for pelvic lymph node dissection/biopsy within 4 weeks.
- Signed written consent and HIPAA authorization
Key exclusion criteria (6 listed)
- Contraindications for MRI
- Claustrophobia, metals in the pelvis, previous pelvic surgery
- Allergy or hypersensitivity to iron products, dextrans, iron-dextran complex
- a. Prostate cancer: metastases demonstrated on preoperative imaging; prior hormonal therapy greater than 3 months; prior local therapy for prostate cancer b. Penile Cancer: prior systemic therapy for penile cancer; prior inguinal radiation c. Bladder Cancer: prior systemic therapy for bladder cancer (does NOT include intravesical chemotherapy or immunotherapy); prior pelvic radiation; history of partial cystectomy or prior pelvic lymph node dissection
- Women of child-bearing potential. (Women who will be having hysterectomy as part of bladder surgery will not be excluded.)
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 |
|---|---|---|
| Ferumoxtran-10 (USPIO)Also: MRI Contrast Agent, Ultra-small superparamagnetic oxide particlesIntravenous infusion of 2.6 mg/kg of ferumoxtran-10 | Drug | Ferumoxtran-10 MRI |
| MR lymphangiographyAlso: MRI, Magnetic Resonance ImagingFirst MRI examination before ferumoxtran-10 contrast injected and second MRI examination about 24 hours after injection of contrast agent, each MRI taking 20 minutes. | Procedure or surgery | Ferumoxtran-10 MRI, MRI |
Primary outcome
Sensitivity of MRI Per Patient
Time frame: MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI
Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UT 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.
Haesun Choi, 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 study testing Ferumoxtran-10 (USPIO) and MR lymphangiography in people with Bladder Cancer and Genitourinary 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 6 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 7 Aug 2012. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Sensitivity of MRI Per Patient (time frame: MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI). 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 7 Aug 2012.