A Phase 1 interventional study of Internal Radiation Therapy and Magnetic Resonance Imaging in Human Papillomavirus-Related Carcinoma, Human Papillomavirus-Related Cervical Carcinoma and Stage IB2 Cervical Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center. Terminated at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.
Sponsored by M.D. Anderson Cancer Center · Phase 1, Interventional, and Treatment
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.
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.
1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.
This study's enrollment of 26 is below the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
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Exclusion Criteria:
Participants undergo MRI scan during internal radiation therapy applicator placement.
Radiation: Internal Radiation Therapy · Procedure: Magnetic Resonance Imaging
Undergo brachytherapy
Also known as: BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy
Undergo MRI scan
Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
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.
Time frame: Up to 4 years
Diffusion weighted imaging (DWI) outcomes
Time frame: Up to 4 years
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.
Time frame: Up to 4 years
Disease recurrence (local, regional, and distant)
determined via axial imaging (MRI or PET/CT) on interval follow-up
Time frame: Up to 4 years
Overall survival
Time frame: Up to 4 years
Progression-free survival
Time frame: Up to 4 years
Incidence and severity of treatment-related toxicities
as defined via CTCAE v4.0
Time frame: Up to 4 years
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.
Time frame: Up to 4 years
This study is terminated, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center