Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy
18 Years
N/A
Female
Cervix Neoplasms, Uterine Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms
Trial Information
Pilot Study of Magnetic Resonance Imaging Guided Brachytherapy
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Insertion of needles into the bladder or rectum
Principal Investigator
Akila N Viswanathan, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
BWH/DFCI
Authority:
United States: Institutional Review Board
Study ID:
03-201
NCT ID:
NCT00112307
Start Date:
March 2003
Completion Date:
October 2005
Related Keywords:
- Cervix Neoplasms
- Uterine Neoplasms
- Vaginal Neoplasms
- Vulvar Neoplasms
- MRI
- Brachytherapy
- Carcinoma
- Cervix
- Uterus
- Vagina
- Vulva
- Carcinoma of the cervix
- Carcinoma of the uterus
- Carcinoma of the vagina
- Carcinoma of the vulva
- Neoplasms
- Uterine Cervical Neoplasms
- Uterine Neoplasms
- Vaginal Neoplasms
- Vulvar Neoplasms
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