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Completed

NCT Number: NCT00112307

Magnetic Resonance Imaging Guided Gynecologic Brachytherapy

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brachytherapy

Procedure

Primary outcomes

  1. Insertion of needles into the bladder or rectum

Secondary outcomes

  1. Ability of MR imaging to accurately determine tumor, bladder and rectal volumes

  2. Assessment of acute skin, genitourinary and gastrointestinal toxicities

  3. Assessment of tumor progression or recurrence during a 180 day follow-up period

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy

Important dates

Study start
2003
Study completion
2005
First posted
Jun 2, 2005
Registry last updated
Sep 17, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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