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Trial record 9 of 197 for:    Vaginal Cancer: Clinical Trials

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

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ClinicalTrials.gov Identifier: NCT03634267
Recruitment Status : Recruiting
First Posted : August 16, 2018
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

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.

Condition or disease Intervention/treatment Phase
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 Radiation: Internal Radiation Therapy Procedure: Magnetic Resonance Imaging Not Applicable

Detailed 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 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MRI Guided Brachytherapy for HPV-Associated Cervical and Vaginal Malignancies
Actual Study Start Date : August 3, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (MRI, internal radiation therapy)
Participants undergo MRI scan during internal radiation therapy applicator placement.
Radiation: Internal Radiation Therapy
Undergo brachytherapy
Other Names:
  • BRACHYTHERAPY
  • internal radiation
  • Internal Radiation Brachytherapy
  • Radiation Brachytherapy

Procedure: Magnetic Resonance Imaging
Undergo MRI scan
Other Names:
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MRI
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging




Primary Outcome Measures :
  1. Percent of patients achieving high-risk clinical target volume (HR-CTV) dose to 90% (D90) [ Time Frame: Up to 4 years ]
    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 MRI guided placement) treatment plan for each patient using McNemar's test.


Secondary Outcome Measures :
  1. Diffusion weighted imaging (DWI) outcomes as assessed by tumor aspirate cytology [ Time Frame: Up to 4 years ]
  2. Biomarker measurements (tumor viability and tumor T cell profile) from tumor samples [ Time Frame: Up to 4 years ]
    A paired t-test will be used to compare apparent diffusion coefficient (ADC) areas for each biomarker.

  3. Clinical and disease outcome assessed by fine needle aspiration of the tumor [ Time Frame: Up to 4 years ]
  4. Cost difference associated with the MRI-guided versus the standard process [ Time Frame: Up to 4 years ]
    Billing and financial data will be calculated and compared to that of the conventional non-MRI-guided brachytherapy approach.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women with stage 1B2-IVA cervical cancer recommended to receive definitive chemoradiation including brachytherapy.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03634267


Contacts
Contact: Ann Klopp 713-563-2300 aklopp@mdanderson.org

Locations
United States, Texas
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact       aklopp@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Ann Klopp M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03634267     History of Changes
Other Study ID Numbers: 2017-0823
NCI-2018-01569 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2017-0823 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Vaginal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Vaginal Diseases
Carcinoma
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female