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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00188695
Other study ID # 03-0838-C
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2004
Est. completion date March 15, 2022

Study information

Verified date October 2022
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 61
Est. completion date March 15, 2022
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
Canada Princess Margaret Hospital Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University Health Network, Toronto Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers. once at time of imaging
Primary 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 Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy. once at time of imaging
Secondary Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers. once at time of imaging
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