Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

NCT00188695CompletedPHASE1, PHASE2INTERVENTIONAL

Summary

Key Facts

Lead Sponsor

University Health Network, Toronto

Enrollment

61

Start Date

2004-04-01

Completion Date

2006-06-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

MRI contrast agent Combidex (ferumoxtran-10)

Conditions

Uterine NeoplasmsCervix NeoplasmsBladder NeoplasmsProstatic Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

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

Outcome Measures

Primary Outcomes

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 Outcomes

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

Locations

Princess Margaret Hospital, Toronto, Canada

Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide