Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112307
Status:
COMPLETED
Last Update Posted:
2009-09-17
First Post:
2005-06-01
Brief Title:
Magnetic Resonance Imaging Guided Gynecologic Brachytherapy
Sponsor:
Brigham and Womens Hospital
Organization:
Brigham and Womens Hospital
Study Overview
Official Title:
Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy
Status:
COMPLETED
Status Verified Date:
2009-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 Womens 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None