Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

Phase 1

Completed

• Conditions: Cervix Neoplasms; Uterine Neoplasms; Bladder Neoplasms; Prostatic Neoplasms

• Registration Number: NCT00188695
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-16
• Primary Completion: 2006-06
• Study Completion: 2022-03-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

Inclusion Criteria

• histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer
• no distant metastases
• informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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
Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.	once at time of imaging

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada