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Magnetic Resonance Imaging Guided Gynecologic Brachytherapy

NCT00112307CompletedNAINTERVENTIONAL

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

Key Facts

Lead Sponsor

Brigham and Women's Hospital

Enrollment

Start Date

2003-03-01

Study Type

INTERVENTIONAL

Official Title

Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy

Interventions

Brachytherapy

Conditions

Cervix NeoplasmsUterine NeoplasmsVaginal NeoplasmsVulvar Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Insertion of needles into the bladder or rectum

Secondary Outcomes

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

Linked Diseases

Uterine Neoplasms

Uterine Neoplasms — a type of gynecological cancer.

Vaginal Neoplasms

Vaginal Neoplasms — a type of gynecological cancer.

Vulvar Neoplasms

Vulvar Neoplasms — a type of gynecological cancer.