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Clinical Trials/NCT00188695
NCT00188695CompletedPhase 1

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

University Health Network, Toronto2 sites in 1 country61 target enrollmentStarted: April 2004Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
61
Locations
2
Primary Endpoint
Improved clinical target volume (CTV) definition for the purpose of adjuvant irradiation of pelvic lymph nodes using intensity modulated radiotherapy (IMRT).
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

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

Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.

Time Frame: once at time of imaging

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (2)

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