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


Phase 1/Phase 2
18 Years
N/A
Not Enrolling
Both
Uterine Neoplasms, Cervix Neoplasms, Bladder Neoplasms, Prostatic Neoplasms

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

once at time of imaging

Safety Issue:

No

Principal Investigator

Michael Milosevic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Health Canada

Study ID:

03-0838-C

NCT ID:

NCT00188695

Start Date:

April 2004

Completion Date:

June 2006

Related Keywords:

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

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