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Magnetic Resonance Imaging Guided Gynecologic Brachytherapy

This study has been completed.
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00112307
First received: June 1, 2005
Last updated: September 15, 2009
Last verified: September 2009
  Purpose

The primary goal of this pilot study is to assess the feasibility of using magnetic resonance (MR) imaging guidance in the Magnetic Resonance Therapy (MRT) unit at the Brigham and Women's Hospital during the implantation of brachytherapy applicators in patients with gynecologic malignancies. Patients with gynecologic malignancies requiring brachytherapy are currently treated under either fluoroscopic or CT visualization of the brachytherapy applicator. Magnetic resonance imaging has been shown in many studies to provide superior visualization of the cervix, vagina and uterus compared to CT. However no prior study has examined the feasibility of using real-time magnetic resonance imaging to assist in the guidance of gynecologic brachytherapy applicators


Condition Intervention
Cervix Neoplasms
Uterine Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Procedure: Brachytherapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy

Resource links provided by NLM:


Further study details as provided by Brigham and Women's Hospital:

Primary Outcome Measures:
  • Insertion of needles into the bladder or rectum

Secondary Outcome Measures:
  • Ability of MR imaging to accurately determine tumor, bladder and rectal volumes
  • Assessment of acute skin, genitourinary and gastrointestinal toxicities
  • Assessment of tumor progression or recurrence during a 180 day follow-up period

Estimated Enrollment: 15
Study Start Date: March 2003
Estimated Study Completion Date: October 2005
Detailed Description:

The primary endpoint involves the ability of the MRT guided procedure to protect bladder and rectal tissues from inadvertent insertion of the interstitial needles used to deliver brachytherapy. MR images obtained on the MRT unit should provide clear delineation of the bladder and rectum and allow for greater accuracy and avoidance of these normal tissues upon interstitial needle insertion. CT images will be obtained following the insertion of needles using the MRT unit. The procedure will be considered a failure if CT imaging identifies the insertion of needles into the bladder or rectum that was not detected using MR. Secondary endpoints include the ability of MR imaging to accurately reconstruct dosimetric plans and to construct dose volume histograms after the implantation of interstitial needles as well as the ability of MR imaging to accurately determine tumor, bladder and rectal volumes. Secondary endpoints will also include the assessment of acute skin, genitourinary and gastrointestinal toxicities as well as an assessment of tumor progression or recurrence during a 180 day follow-up period.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologic documentation of carcinoma. Carcinoma of the cervix: Stage IIIB, IVA or vaginal recurrence
  • Carcinoma of the cervix: Stage IB, IIA, IIB or IIIA with obliteration of the cervical os (tandem and ovoid implant not feasible)
  • Carcinoma of the uterus: Stage IIIB (vaginal involvement) or vaginal recurrence
  • Carcinoma of the vagina: Stage II, III, IVA or vaginal recurrence
  • Carcinoma of the vulva: T3 (vaginal extension) or T4 (inoperable - any N stage), or vaginal recurrence
  • MRI and CT of the pelvis within 2 months before registration
  • ECOG performance status of < 2
  • Age > 18
  • Signed informed consent
  • No metallic objects or pacemakers in the patient
  • Negative pregnancy test for those of child-bearing potential
  • Patients who have received prior radiation or chemotherapy may be enrolled on this study.
  • Documented complete blood count (CBC) with hematocrit (Hct)>30, absolute neutrophil count (ANC)>500, platelet (Plt) >40

Exclusion Criteria:

  • Patients with distant metastasis.
  • Baseline studies not obtained.
  • Patients who are pregnant or lactating.
  • Significant history of cardiovascular disease.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00112307

Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
Principal Investigator: Akila N Viswanathan, MD, MPH BWH/DFCI
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00112307     History of Changes
Obsolete Identifiers: NCT00165113
Other Study ID Numbers: 03-201
Study First Received: June 1, 2005
Last Updated: September 15, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Brigham and Women's Hospital:
MRI
Brachytherapy
Carcinoma
Cervix
Uterus
Vagina
Vulva
Carcinoma of the cervix
Carcinoma of the uterus
Carcinoma of the vagina
Carcinoma of the vulva

Additional relevant MeSH terms:
Neoplasms
Uterine Cervical Neoplasms
Uterine Neoplasms
Vaginal Neoplasms
Vulvar Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms by Site
Urogenital Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Vaginal Diseases
Vulvar Diseases

ClinicalTrials.gov processed this record on November 25, 2014