MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer
NCT ID: NCT03634267
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
26 participants
INTERVENTIONAL
2018-08-03
2026-12-31
Brief Summary
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Detailed Description
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I. Determine whether MRI guidance during internal radiation therapy applicator placement improves the high-risk clinical target volume (HR-CTV) D90 (dose to 90% of the high-risk clinical target volume) rate compared to conventional guidance, with ultrasound and freehand technique, for patients with cervical and vaginal cancer.
SECONDARY OBJECTIVES:
I. Identify diffusion weighted MRI image features that can be used to identify sites of viable tumor following external beam radiotherapy as assessed by tumor aspirate cytology.
II. Determine if diffusion weighted MRI findings are associated with immune infiltration as assessed by multi-spectral flow cytometry.
III. Identify potential correlates between clinical outcomes (survival, progression) and these data objectives (brachytherapy dosimetry/therapeutic ratio, diffusion-weighted MRI imaging features, tumor aspirate cytology findings).
IV. Define the financial costs and feasibility of an MRI-guided brachytherapy approach to determine the overall healthcare quality value (outcomes/cost) of this novel approach for application at other brachytherapy centers.
OUTLINE:
Participants undergo MRI scan during internal radiation therapy applicator placement.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (MRI, internal radiation therapy)
Participants undergo MRI scan during internal radiation therapy applicator placement.
Internal Radiation Therapy
Undergo brachytherapy
Magnetic Resonance Imaging
Undergo MRI scan
Interventions
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Internal Radiation Therapy
Undergo brachytherapy
Magnetic Resonance Imaging
Undergo MRI scan
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Women with stage II-IVA vaginal cancer recommended to receive definitive chemoradiation including brachytherapy.
Exclusion Criteria
* Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device or medical condition which precludes MRI acquisition.
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Ann H Klopp
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Related Links
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MD Anderson Cancer Center Website
Other Identifiers
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NCI-2018-01569
Identifier Type: REGISTRY
Identifier Source: secondary_id
2017-0823
Identifier Type: OTHER
Identifier Source: secondary_id
2017-0823
Identifier Type: -
Identifier Source: org_study_id
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