Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

University Health Network, Toronto

Status and phase

Completed

Phase 2

Phase 1

Conditions

Cervix Neoplasms

Uterine Neoplasms

Prostatic Neoplasms

Bladder Neoplasms

Treatments

Procedure: MRI contrast agent Combidex (ferumoxtran-10)

Study type

Interventional

Funder types

Other

Identifiers

NCT00188695

03-0838-C

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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