Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00188695
• Other study ID #: 03-0838-C
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 2004
• Est. completion date: March 15, 2022

Study information

• Verified date: October 2022
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 15, 2022
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Neoplasms
• Cervix Neoplasms
• Neoplasms
• Prostatic Neoplasms
• Urinary Bladder Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved delineation of normal pelvic lymph nodes in patients with uterine, cervical, bladder and prostate cancers.		once at time of imaging
Primary	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	Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.		once at time of imaging
Secondary	Demonstration of the pattern and distribution of pelvic nodal metastases in patients with uterine, cervical, bladder and prostate cancers.		once at time of imaging