search
Back to results

Magnetic Resonance Imaging Guided Gynecologic Brachytherapy

Primary Purpose

Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brachytherapy
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervix Neoplasms focused on measuring MRI, Brachytherapy, Carcinoma, Cervix, Uterus, Vagina, Vulva, Carcinoma of the cervix, Carcinoma of the uterus, Carcinoma of the vagina, Carcinoma of the vulva

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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 Exclusion Criteria: Patients with distant metastasis. Baseline studies not obtained. Patients who are pregnant or lactating. Significant history of cardiovascular disease.

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    June 1, 2005
    Last Updated
    September 15, 2009
    Sponsor
    Brigham and Women's Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00112307
    Brief Title
    Magnetic Resonance Imaging Guided Gynecologic Brachytherapy
    Official Title
    Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2003 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2005 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Brigham and Women's Hospital

    4. Oversight

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
    Keywords
    MRI, Brachytherapy, Carcinoma, Cervix, Uterus, Vagina, Vulva, Carcinoma of the cervix, Carcinoma of the uterus, Carcinoma of the vagina, Carcinoma of the vulva

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    15 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Brachytherapy
    Primary Outcome Measure Information:
    Title
    Insertion of needles into the bladder or rectum
    Secondary Outcome Measure Information:
    Title
    Ability of MR imaging to accurately determine tumor, bladder and rectal volumes
    Title
    Assessment of acute skin, genitourinary and gastrointestinal toxicities
    Title
    Assessment of tumor progression or recurrence during a 180 day follow-up period

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Akila N Viswanathan, MD, MPH
    Organizational Affiliation
    BWH/DFCI
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Magnetic Resonance Imaging Guided Gynecologic Brachytherapy

    We'll reach out to this number within 24 hrs