Magnetic Resonance Imaging Guided Gynecologic Brachytherapy

Uterine Neoplasms Clinical Trial

Official title:

Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00112307
• Other study ID #: 03-201
• Status: Completed
• Phase: N/A
• First received: June 1, 2005
• Last updated: September 15, 2009
• Start date: March 2003
• Est. completion date: October 2005

Study information

• Verified date: September 2009
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

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.

Other known NCT identifiers

• NCT00165113

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: October 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervix Neoplasms
• Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms
• Vaginal Neoplasms
• Vulvar Neoplasms

Intervention

Procedure:
• Brachytherapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insertion of needles into the bladder or rectum
Secondary	Ability of MR imaging to accurately determine tumor, bladder and rectal volumes
Secondary	Assessment of acute skin, genitourinary and gastrointestinal toxicities
Secondary	Assessment of tumor progression or recurrence during a 180 day follow-up period