Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT03634267

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Human Papillomavirus-Related Carcinoma Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Human Papillomavirus-Related Cervical Carcinoma Neoplasms Neoplasms by Site Stage IB2 Cervical Cancer AJCC v8 Stage II Cervical Cancer AJCC v8 Stage II Vaginal Cancer AJCC v8 Stage IIA Cervical Cancer AJCC v8 Stage IIA Vaginal Cancer AJCC v8 Stage IIA1 Cervical Cancer AJCC v8 Stage IIA2 Cervical Cancer AJCC v8 Stage IIB Cervical Cancer AJCC v8 Stage IIB Vaginal Cancer AJCC v8 Stage III Cervical Cancer AJCC v8 Stage III Vaginal Cancer AJCC v8 Stage IIIA Cervical Cancer AJCC v8 Stage IIIB Cervical Cancer AJCC v8 Stage IVA Cervical Cancer AJCC v8 Stage IVA Vaginal Cancer AJCC v8 Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Diseases Vaginal Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Internal Radiation Therapy

Radiation

Undergo brachytherapy

Other names: BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

Magnetic Resonance Imaging

Procedure

Undergo MRI scan

Other names: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Primary outcomes

  1. Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)

    Time frame: 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 outcomes

  1. Diffusion weighted imaging (DWI) outcomes

    Time frame: Up to 4 years

  2. Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples

    Time frame: Up to 4 years

    A paired t-test will be used to compare apparent diffusion coefficient (ADC) areas for each biomarker.

  3. Disease recurrence (local, regional, and distant)

    Time frame: Up to 4 years

    determined via axial imaging (MRI or PET/CT) on interval follow-up

  4. Overall survival

    Time frame: Up to 4 years

  5. Progression-free survival

    Time frame: Up to 4 years

  6. Incidence and severity of treatment-related toxicities

    Time frame: Up to 4 years

    as defined via CTCAE v4.0

  7. Cost difference associated with the MRI-guided versus the standard process

    Time frame: Up to 4 years

    Billing and financial data will be calculated and compared to that of the conventional non-MRI-guided brachytherapy approach.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies

Important dates

Study start
2018
Primary completion
2026
Study completion
2026
First posted
Aug 16, 2018
Registry last updated
Apr 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.