Magnetic Resonance Imaging Guided Gynecologic Brachytherapy

NCT00112307 | Completed

• 1 other identifier: 03-201
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Insertion of needles into the bladder or rectum

Secondary Outcomes (3)

• 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

Interventions

Brachytherapy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with distant metastasis.
• Baseline studies not obtained.
• Patients who are pregnant or lactating.
• Significant history of cardiovascular disease.

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms; Carcinoma

Interventions

Brachytherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases; Vulvar Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Study Officials

• Akila N Viswanathan, MD, MPH

  BWH/DFCI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 1, 2005
• First Posted: June 2, 2005
• Study Start: March 1, 2003
• Study Completion: October 1, 2005
• Last Updated: September 17, 2009

Record last verified: 2009-09