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

Phase 1

Active, not recruiting

Conditions: Stage II Cervical Cancer AJCC v8
Stage II Vaginal Cancer AJCC v8
Stage IIA1 Cervical Cancer AJCC v8
Stage IIB Vaginal Cancer AJCC v8
Stage III Cervical Cancer AJCC v8
Stage IIIA Cervical Cancer AJCC v8
Human Papillomavirus-Related Carcinoma
Stage IIA Cervical Cancer AJCC v8
Stage IIA Vaginal Cancer AJCC v8
Stage IIB Cervical Cancer AJCC v8

Interventions: Radiation: Internal Radiation Therapy
Procedure: Magnetic Resonance Imaging

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Treatment (MRI, internal radiation therapy)	Magnetic Resonance Imaging	Participants undergo MRI scan during internal radiation therapy applicator placement.
Treatment (MRI, internal radiation therapy)	Internal Radiation Therapy	Participants undergo MRI scan during internal radiation therapy applicator placement.

Primary Outcome Measures

Name	Time	Method
Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)	Up to 4 years	Rate will be compared to conventional guidance, with ultrasound and freehand technique. We will compare the HR-CTV D90 and other secondary dosimetry parameters (e.g. D2 cc bladder, D2 cc rectum etc.) between the initial scan (subsequent to ultrasound \[US\] guided or freehand applicator placement) and optimized (with magnetic resonance imaging \[MRI\] guided placement) treatment plan for each patient using McNemar's test.

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	Up to 4 years
Diffusion weighted imaging (DWI) outcomes	Up to 4 years
Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples	Up to 4 years	A paired t-test will be used to compare apparent diffusion coefficient (ADC) areas for each biomarker.
Overall survival	Up to 4 years
Disease recurrence (local, regional, and distant)	Up to 4 years	determined via axial imaging (MRI or PET/CT) on interval follow-up
Cost difference associated with the MRI-guided versus the standard process	Up to 4 years	Billing and financial data will be calculated and compared to that of the conventional non-MRI-guided brachytherapy approach.
Incidence and severity of treatment-related toxicities	Up to 4 years	as defined via CTCAE v4.0