Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

NCT ID: NCT00188695

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2022-03-15

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.

Conditions

Uterine Neoplasms; Cervix Neoplasms; Bladder Neoplasms; Prostatic Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Interventions

MRI contrast agent Combidex (ferumoxtran-10)

Combidex as an MR-lymph node contrast agent for the detection of small lymph nodes and lymph metastases.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

University Health Network

Principal Investigators

Michael Milosevic, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

03-0838-C

Identifier Type: -

Identifier Source: org_study_id