Status:
COMPLETED
Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide
Lead Sponsor:
University Health Network, Toronto
Collaborating Sponsors:
Princess Margaret Hospital, Canada
Conditions:
Uterine Neoplasms
Cervix Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 Magn...
Eligibility Criteria
Inclusion
- histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer
- no distant metastases
- informed consent
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2022
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00188695
Start Date
April 1 2004
End Date
March 15 2022
Last Update
October 7 2022
Active Locations (1)
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1
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9