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

NCT03634267 | Active Not Recruiting Phase 1

• 3 other identifiers: 2017-0823NCI-2018-01569P30CA016672
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Human Papillomavirus-Related Carcinoma; Stage II Cervical Cancer AJCC v8; Human Papillomavirus-Related Cervical Carcinoma; Stage IB2 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Diffusion weighted imaging (DWI) outcomes

  Up to 4 years

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

  Up to 4 years

• Disease recurrence (local, regional, and distant)

  Up to 4 years

• Overall survival

  Up to 4 years

• Progression-free survival

  Up to 4 years

Study Arms (1)

Treatment (MRI, internal radiation therapy)

EXPERIMENTAL

Participants undergo MRI scan during internal radiation therapy applicator placement.

Radiation: Internal Radiation Therapy; Procedure: Magnetic Resonance Imaging

Interventions

Internal Radiation Therapy RADIATION

Undergo brachytherapy

Also known as: BRACHYTHERAPY, internal radiation, Internal Radiation Brachytherapy, Radiation Brachytherapy

Treatment (MRI, internal radiation therapy)

Magnetic Resonance Imaging PROCEDURE

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

Treatment (MRI, internal radiation therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• MD Anderson Cancer Center Website

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Vaginal Neoplasms

Interventions

Brachytherapy; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Ann H Klopp

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2018
• First Posted: August 16, 2018
• Study Start: August 3, 2018
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Locations

US (1)