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

Human Papillomavirus-Related Carcinoma Clinical Trial

Official title:

MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03634267
• Other study ID #: 2017-0823
• Secondary ID: NCI-2018-0156920
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: August 3, 2018
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 26
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Carcinoma
• Human Papillomavirus-Related Carcinoma
• Human Papillomavirus-Related Cervical Carcinoma
• 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
• Uterine Cervical Neoplasms
• Vaginal Neoplasms

Intervention

Radiation:
• Internal Radiation Therapy
Undergo brachytherapy

Procedure:
• Magnetic Resonance Imaging
Undergo MRI scan

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90)	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	Diffusion weighted imaging (DWI) outcomes		Up to 4 years
Secondary	Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples	A paired t-test will be used to compare apparent diffusion coefficient (ADC) areas for each biomarker.	Up to 4 years
Secondary	Disease recurrence (local, regional, and distant)	determined via axial imaging (MRI or PET/CT) on interval follow-up	Up to 4 years
Secondary	Overall survival		Up to 4 years
Secondary	Progression-free survival		Up to 4 years
Secondary	Incidence and severity of treatment-related toxicities	as defined via CTCAE v4.0	Up to 4 years
Secondary	Cost difference associated with the MRI-guided versus the standard process	Billing and financial data will be calculated and compared to that of the conventional non-MRI-guided brachytherapy approach.	Up to 4 years

External Links

•   MD Anderson Cancer Center Website