Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

NCT00188695 | Completed Phase 1 DMC

• 1 other identifier: 03-0838-C
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

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

  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).

  once at time of imaging

Secondary Outcomes (2)

• 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

Interventions

MRI contrast agent Combidex (ferumoxtran-10) PROCEDURE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• histologically confirmed endometrial, cervix, prostate (cT1-cT3) or bladder cancer
• no distant metastases
• informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Princess Margaret Hospital, Canada: collaborator

Study Sites (1)

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Uterine Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Prostatic Neoplasms

Interventions

ferumoxtran-10

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Cervical Diseases; Urologic Neoplasms; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Prostatic Diseases

Study Officials

• Michael Milosevic, MD

  Princess Margaret Hospital, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 16, 2005
• Study Start: April 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: March 15, 2022
• Last Updated: October 7, 2022

Record last verified: 2022-10

Locations

CA (1)