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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status and phase

Active, not recruiting
Phase 1

Conditions

Stage IIB Vaginal Cancer AJCC v8
Stage IIIA Cervical Cancer AJCC v8
Stage III Cervical Cancer AJCC v8
Stage II Vaginal Cancer AJCC v8
Human Papillomavirus-Related Carcinoma
Stage IIA2 Cervical Cancer AJCC v8
Stage IVA Vaginal Cancer AJCC v8
Stage IIA Cervical Cancer AJCC v8
Stage IIIB Cervical Cancer AJCC v8
Stage IIA1 Cervical Cancer AJCC v8
Stage II Cervical Cancer AJCC v8
Stage IB2 Cervical Cancer AJCC v8
Stage IVA Cervical Cancer AJCC v8
Stage IIB Cervical Cancer AJCC v8
Stage III Vaginal Cancer AJCC v8
Stage IIA Vaginal Cancer AJCC v8
Human Papillomavirus-Related Cervical Carcinoma

Treatments

Radiation: Internal Radiation Therapy
Procedure: Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03634267
P30CA016672 (U.S. NIH Grant/Contract)
2017-0823 (Other Identifier)
NCI-2018-01569 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

26 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

26 participants in 1 patient group

Treatment (MRI, internal radiation therapy)
Experimental group
Description:
Participants undergo MRI scan during internal radiation therapy applicator placement.
Treatment:
Procedure: Magnetic Resonance Imaging
Radiation: Internal Radiation Therapy

Trial contacts and locations

1

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Central trial contact

Ann Klopp

Data sourced from clinicaltrials.gov

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