Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Study of MR Imaging With Ultra-small Superparamagnetic Iron Oxide for Pelvic Lymph Node Target Definition

Conditions
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Uterine Neoplasms, Cervix Neoplasms, Bladder Neoplasms, Prostatic Neoplasms

Intervention / Treatment
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* Procedure: MRI contrast agent Combidex (ferumoxtran-10)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer no distant metastases informed consent Exclusion Criteria: confirmed prostate carcinoma and PSA less than or equal to 4 or greater than 100 radical surgery or prior cryosurgery for prostate carcinoma, previous RT, hormonal manipulation or chemotherapy biopsy-proven lymph node involvement endometrium or cervix carcinoma who have undergone recent pelvic surgery with the exclusion of D&C or biopsy bladder carcinoma with recent pelvic surgery with the exclusion of TURBT previous or concurrent cancers other than superficial basal or squamous cell skin carcinoma unless disease-free for at least 5 yrs contraindication to MR imaging hip prosthesis major medical or psychiatric illness patients with known allergy to dextran or iron-containing compounds patients with cirrhosis or hemochromatosis patients receiving another MR contrast within 2 hrs prior to the ferumoxtran-10

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: MRI contrast agent Combidex (ferumoxtran-10)|Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | once at time of imaging |