Bladder Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT03634267

Recruitment Status:

Recruiting

Sponsor:

M.D. Anderson Cancer Center

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There is 1 Location for this study

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M D Anderson Cancer Center
Houston Texas, 77030, United States More Info
Ann H. Klopp
Contact
713-563-2300
Ann H. Klopp
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

60

Study ID:

NCT03634267

Recruitment Status:

Recruiting

Sponsor:


M.D. Anderson Cancer Center

How clear is this clinincal trial information?

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