Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

Sponsor

University Health Network, Toronto (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT00188695

Collaborator

Princess Margaret Hospital, Canada (Other)

Enrollment

Location

222

Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Neoplasms Cervix Neoplasms Bladder Neoplasms Prostatic Neoplasms	Procedure: MRI contrast agent Combidex (ferumoxtran-10)	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

A Pilot Study of MR Imaging With Ultra-small Superparamagnetic Iron Oxide for Pelvic Lymph Node Target Definition

Study Start Date :

Apr 1, 2004

Actual Primary Completion Date :

Jun 1, 2006

Anticipated Study Completion Date :

Oct 1, 2022

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto
Princess Margaret Hospital, Canada

Investigators

Principal Investigator: Michael Milosevic, MD, Princess Margaret Hospital, Canada

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00188695

Other Study ID Numbers:

03-0838-C

First Posted:

Sep 16, 2005

Last Update Posted:

Apr 12, 2022

Last Verified:

Apr 1, 2022

Additional relevant MeSH terms:

Neoplasms

Prostatic Neoplasms

Urinary Bladder Neoplasms

Uterine Neoplasms

Uterine Cervical Neoplasms

Study Results

No Results Posted as of Apr 12, 2022