Bladder Neoplasms, Cervix Neoplasms, Prostatic Neoplasms, Uterine Neoplasms
Conditions
Brief summary
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.
Interventions
PROCEDUREMRI contrast agent Combidex (ferumoxtran-10)
Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases.
Sponsors
Princess Margaret Hospital, Canada
University Health Network, Toronto
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Canada
Outcome results
None listed