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Active Not RecruitingNCT03634267

MRI-Guided Brachytherapy in Treating Participants With HPV-Associated Stage IB2-IVA Cervical or Stage II-IVA Vaginal Cancer

MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
26 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

This trial studies how well magnetic resonance imaging (MRI)-guided internal radiation therapy (brachytherapy) works in treating participants with human papillomavirus (HPV) associated stage IB2-IV cervical or stage II-IVA vaginal cancer. Using MRI guidance during brachytherapy applicator placement may improve treatment planning in participants with cervical or vaginal cancer.

Detailed description

PRIMARY OBJECTIVES: 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

Interventions

TypeNameDescription
RADIATIONInternal Radiation TherapyUndergo brachytherapy
PROCEDUREMagnetic Resonance ImagingUndergo MRI scan

Timeline

Start date
2018-08-03
Primary completion
2026-12-31
Completion
2026-12-31
First posted
2018-08-16
Last updated
2026-04-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03634267. Inclusion in this directory is not an endorsement.