Clinical Trials Logo

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
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Active, not recruiting NCT02379520 - HPV-16/18 E6/E7-Specific T Lymphocytes, Relapsed HPV-Associated Cancers, HESTIA Phase 1
Completed NCT02624349 - Immunogenicity and Safety of Human Papilloma Virus Vaccine in Solid Organ Transplant Recipients Phase 4
Recruiting NCT04474821 - HPV Educational Intervention to Increase Acceptance and Completion of Free HPV Vaccination Among Underserved Adults Phase 4
Withdrawn NCT05472220 - Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma Phase 1
Active, not recruiting NCT02568566 - Recombinant Human Papillomavirus Nonavalent Vaccine in Preventing Human Papilloma Virus in Younger Healthy Participants Phase 2
Recruiting NCT05232851 - A Vaccine (PDS0101) Alone or in Combination With Pembrolizumab for the Treatment of Locally Advanced Human Papillomavirus-Associated Oropharynx Cancer Phase 1/Phase 2
Not yet recruiting NCT05985681 - Testing RG1-VLP Vaccine to Prevent HPV-related Cancers Phase 1
Completed NCT04189003 - Molecular Signatures of HPV+ ORL Cancers (OROPAP)
Recruiting NCT04927650 - Prevention and Early Detection of Cervical Cancer Through Self-Administered Screening
Completed NCT01769560 - MeFirst: A Tailored Intervention to HPV Vaccine Decision Making N/A
Recruiting NCT05831540 - Clinical Decision Support Tools to Increase Human Papillomavirus (HPV) Vaccination in Adolescents in Pharmacies N/A
Active, not recruiting NCT04580446 - HYHOPE: De-intensified Hypofractionated Radiation Therapy for HPV-associated Oropharynx Cancer Phase 1
Not yet recruiting NCT04142398 - Incidence of HPV Infection and HPV-Associated Disease in Screening Indian Men Who Have Sex With HIV-Positive Men
Completed NCT04880837 - Human Papillomavirus Education Programs N/A