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Completed

NCT Number: NCT00188695

Combidex USPIO - Ultra-small Superparamagnetic Iron Oxide

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: once at time of imaging

  2. 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

  1. Comparison of target lymph node delineation between nodal imaging with USPIO and volume expansion of vascular anatomy.

    Time frame: once at time of imaging

  2. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2022
First posted
Sep 16, 2005
Registry last updated
Oct 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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