Status:
COMPLETED
Magnetic Resonance Imaging Guided Gynecologic Brachytherapy
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Cervix Neoplasms
Uterine Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
NA
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 dur...
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 ima...
Eligibility Criteria
Inclusion
- 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
- Patients with distant metastasis.
- Baseline studies not obtained.
- Patients who are pregnant or lactating.
- Significant history of cardiovascular disease.
Key Trial Info
Start Date :
March 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00112307
Start Date
March 1 2003
End Date
October 1 2005
Last Update
September 17 2009
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