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| Name | Class |
|---|---|
| Princess Margaret Hospital, Canada | OTHER |
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The purpose of this study is to test whether or not a new contrast agent called Combidex, a contrast agent formulated from ultra-small superparamagnetic iron oxide (USPIO) improves the ability of Magnetic Resonance Imaging (MRI) to see lymph nodes in the pelvis. It might also help doctors tell whether or not cancer has spread to these lymph nodes. It might allow radiotherapy to be delivered more accurately.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI contrast agent Combidex (ferumoxtran-10) | Procedure | Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases. |
| Measure | Description | Time Frame |
|---|---|---|
| Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers. | once at time of imaging | |
| Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT). | once at time of imaging |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy. | once at time of imaging | |
| Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Milosevic, MD | Princess Margaret Hospital, Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D002583 | Uterine Cervical Neoplasms |
| D001749 | Urinary Bladder Neoplasms |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C097921 | ferumoxtran-10 |
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| once at time of imaging |
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D002577 | Uterine Cervical Diseases |
| D014571 | Urologic Neoplasms |
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D005834 | Genital Neoplasms, Male |
| D005832 | Genital Diseases, Male |
| D011469 | Prostatic Diseases |