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

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 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.

Inclusion Criteria:

- Women with stage 1B2-IVA cervical cancer recommended to receive definitive
chemoradiation including brachytherapy.

- Women with stage II-IVA vaginal cancer recommended to receive definitive
chemoradiation including brachytherapy.

Exclusion Criteria:

- Patient or tumor anatomy that requires use of a non-MRI-compatible applicator.

- Patients with implantable cardioverter-defibrillator, pacemaker or other implanted
device or medical condition which precludes MRI acquisition.