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Combidex USPIO - Ultra-Small Superparamagnetic Iron Oxide

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00188695
First Posted: September 16, 2005
Last Update Posted: May 7, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Princess Margaret Hospital, Canada
Information provided by:
University Health Network, Toronto
  Purpose
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 Intervention Phase
Uterine Neoplasms Cervix Neoplasms Bladder Neoplasms Prostatic Neoplasms Procedure: MRI contrast agent Combidex (ferumoxtran-10) Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers. [ Time Frame: 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). [ Time Frame: 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. [ Time Frame: once at time of imaging ]
  • 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 ]

Enrollment: 61
Study Start Date: April 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00188695


Locations
Canada, Ontario
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
  More Information

Responsible Party: Dr. Michael Milosevic, Principal Investigator, University Health Network
ClinicalTrials.gov Identifier: NCT00188695     History of Changes
Other Study ID Numbers: 03-0838-C
First Submitted: September 12, 2005
First Posted: September 16, 2005
Last Update Posted: May 7, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Neoplasms
Prostatic Neoplasms
Urinary Bladder Neoplasms
Uterine Neoplasms
Uterine Cervical Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Genital Neoplasms, Female
Uterine Diseases
Genital Diseases, Female
Uterine Cervical Diseases
Dextrans
Anticoagulants
Plasma Substitutes
Blood Substitutes