A Validation Study of MR Lymphangiography Using SPIO, a New Lymphotropic Superparamagnetic Nanoparticle Contrast

NCT00147238 | Terminated Results

• 1 other identifier: 2004-0003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical research study is to evaluate how well ferumoxtran-10, a new Magnetic Resonance Imaging (MRI) contrast agent, can detect cancer in the pelvic lymph nodes or malignant pelvic lymph nodes.

Conditions

Bladder Cancer; Genitourinary Cancer; Prostate Cancer

Keywords

Bladder Cancer; Genitourinary Cancer; Prostate Cancer; MR Lymphangiography; Ferumoxtran-10; SPIO; Ultra-small superparamagnetic agent iron oxide

Outcome Measures

Primary Outcomes (1)

• Sensitivity of MRI Per Patient

  Sensitivity of MRI on a per patient basis using two-sided McNemar test to detect differences in the sensitivities of two paired MR images (one with and one without ferumoxtran-10 contrast agent). Sensitivity of images written as percentage in decimal form: 0.0 (low) to 1.0 (high).

  MRI without ferumoxtran-10 contrast and second repeated MRI with contrast agent within 24-36 hours of contrast injection, about 24 hours after first MRI

Study Arms (2)

Ferumoxtran-10 MRI

EXPERIMENTAL

MR lymphangiography using Ferumoxtran-10 contrast agent.

Drug: Ferumoxtran-10 (USPIO); Procedure: MR lymphangiography

MRI

ACTIVE COMPARATOR

MR lymphangiography before injecting Ferumoxtran-10 contrast agent.

Procedure: MR lymphangiography

Interventions

Ferumoxtran-10 (USPIO) DRUG

Intravenous infusion of 2.6 mg/kg of ferumoxtran-10

Also known as: MRI Contrast Agent, Ultra-small superparamagnetic oxide particles

Ferumoxtran-10 MRI

MR lymphangiography PROCEDURE

First MRI examination before ferumoxtran-10 contrast injected and second MRI examination about 24 hours after injection of contrast agent, each MRI taking 20 minutes.

Also known as: MRI, Magnetic Resonance Imaging

Ferumoxtran-10 MRI; MRI

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed pelvic urological tumors, including prostate carcinomas, bladder carcinomas, and penile carcinomas.
• Planned to have a surgical exploration or a laparoscopy for pelvic lymph node dissection/biopsy within 4 weeks.
• Signed written consent and HIPAA authorization

You may not qualify if:

• Contraindications for MRI
• Claustrophobia, metals in the pelvis, previous pelvic surgery
• Allergy or hypersensitivity to iron products, dextrans, iron-dextran complex
• a. Prostate cancer: metastases demonstrated on preoperative imaging; prior hormonal therapy greater than 3 months; prior local therapy for prostate cancer b. Penile Cancer: prior systemic therapy for penile cancer; prior inguinal radiation c. Bladder Cancer: prior systemic therapy for bladder cancer (does NOT include intravesical chemotherapy or immunotherapy); prior pelvic radiation; history of partial cystectomy or prior pelvic lymph node dissection
• Women of child-bearing potential. (Women who will be having hysterectomy as part of bladder surgery will not be excluded.)
• Clinically documented or risk of primary or secondary iron overloading (e.g.History of thalassemia, sickle cell anemia, hereditary hemochromatosis, multiple transfusions with any reason)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

U.T.M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center website

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Urogenital Neoplasms; Prostatic Neoplasms

Interventions

ferumoxtran-10; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Haesun Choi, MD / Professor
• Organization: UT MD Anderson Cancer Center

713-745-4693

Study Officials

• Haesun Choi, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 7, 2005
• Study Start: July 1, 2005
• Primary Completion: January 1, 2007
• Study Completion: January 1, 2007
• Last Updated: August 7, 2012
• Results First Posted: January 27, 2010

Record last verified: 2012-07

Locations

US (1)