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

June 1, 2005
September 15, 2009
March 2003
Not Provided
Insertion of needles into the bladder or rectum
Same as current
Complete list of historical versions of study NCT00112307 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Magnetic Resonance Imaging Guided Gynecologic Brachytherapy
Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy

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

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Cervix Neoplasms
  • Uterine Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms
Procedure: Brachytherapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
October 2005
Not Provided

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00112307
03-201
Not Provided
Not Provided
Brigham and Women's Hospital
Not Provided
Principal Investigator: Akila N Viswanathan, MD, MPH BWH/DFCI
Brigham and Women's Hospital
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP