Clinical trial · Interventional
A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast
NCT00147238CI-TRIAL-00007760terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated at request of sponsor.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Genitourinary Cancer | Malignant Genitourinary System Neoplasm | ALIAS | 0.90 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ferumoxtran-10 (USPIO) | Drug | — | UNRESOLVED |
| MR lymphangiography | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Ferumoxtran-10 MRI
- description
- MR lymphangiography using Ferumoxtran-10 contrast agent.
- interventionNames
- Drug: Ferumoxtran-10 (USPIO)
- Procedure: MR lymphangiography
- type
- ACTIVE_COMPARATOR
- label
- MRI
- description
- MR lymphangiography before injecting Ferumoxtran-10 contrast agent.
- interventionNames
- Procedure: MR lymphangiography
Primary outcomes (1)
- measure
- Sensitivity of MRI Per Patient
- timeFrame
- 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
Eligibility
Eligibility (as posted)
- Sex
- Male
Show eligibility criteria text
Inclusion Criteria: 1. Patients with newly diagnosed pelvic urological tumors, including prostate carcinomas, bladder carcinomas, and penile carcinomas. 2. Planned to have a surgical exploration or a laparoscopy for pelvic lymph node dissection/biopsy within 4 weeks. 3. Signed written consent and HIPAA authorization Exclusion Criteria: 1. Contraindications for MRI 2. Claustrophobia, metals in the pelvis, previous pelvic surgery 3. Allergy or hypersensitivity to iron products, dextrans, iron-dextran complex 4. 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 5. Women of child-bearing potential. (Women who will be having hysterectomy as part of bladder surgery will not be excluded.) 6. 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)
References
Publications (0)
Data not yet available
No reference posted for this study.