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Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

Primary Purpose

Uterine Neoplasms, Cervix Neoplasms, Bladder Neoplasms

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
MRI contrast agent Combidex (ferumoxtran-10)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterine Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.
Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).

Secondary Outcome Measures

Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.
Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers.

Full Information

First Posted
September 12, 2005
Last Updated
October 6, 2022
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00188695
Brief Title
Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide
Official Title
A Pilot Study of MR Imaging With Ultra-small Superparamagnetic Iron Oxide for Pelvic Lymph Node Target Definition
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 2004 (Actual)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
March 15, 2022 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Neoplasms, Cervix Neoplasms, Bladder Neoplasms, Prostatic Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
MRI contrast agent Combidex (ferumoxtran-10)
Intervention Description
Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases.
Primary Outcome Measure Information:
Title
Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.
Time Frame
once at time of imaging
Title
Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).
Time Frame
once at time of imaging
Secondary Outcome Measure Information:
Title
Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.
Time Frame
once at time of imaging
Title
Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers.
Time Frame
once at time of imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Milosevic, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

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