Magnetic Resonance Imaging Guided Gynecologic Brachytherapy

Sponsor

Brigham and Women's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00112307

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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 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 or Disease	Intervention/Treatment	Phase
Cervix Neoplasms Uterine Neoplasms Vaginal Neoplasms Vulvar Neoplasms	Procedure: Brachytherapy	N/A

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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy

Study Start Date :

Mar 1, 2003

Study Completion Date :

Oct 1, 2005

Outcome Measures

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 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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