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

April 9, 2024 updated by: M.D. Anderson Cancer Center

MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • M D Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment (MRI, internal radiation therapy)
Participants undergo MRI scan during internal radiation therapy applicator placement.
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Other Names:
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy
  • BRACHYTHERAPY
  • internal radiation
Procedure: Magnetic Resonance Imaging
Undergo MRI scan
Other Names:
  • MRI
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: Up to 4 years
Up to 4 years
Diffusion weighted imaging (DWI) outcomes
Time Frame: Up to 4 years
Up to 4 years
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.
Up to 4 years
Disease recurrence (local, regional, and distant)
Time Frame: Up to 4 years
determined via axial imaging (MRI or PET/CT) on interval follow-up
Up to 4 years
Progression-free survival
Time Frame: Up to 4 years
Up to 4 years
Incidence and severity of treatment-related toxicities
Time Frame: Up to 4 years
as defined via CTCAE v4.0
Up to 4 years
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.
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Ann H Klopp, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 3, 2018

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 14, 2018

First Posted (Actual)

August 16, 2018

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 9, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-0823 (Other Identifier: M D Anderson Cancer Center)
  • P30CA016672 (U.S. NIH Grant/Contract)
  • NCI-2018-01569 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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