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Brachytherapy Innovations in Gynecologic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04530019
Recruitment Status : Not yet recruiting
First Posted : August 28, 2020
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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Brief Summary:
In this pilot study, the investigators will test tools designed to more precisely identify, define and create a radiation treatment plan to tumor remnants as separate from fibrotic or normal tissue in a Magnetic Resonance (MR) simulator in the department of radiation oncology. The investigators will examine if this beneficial for tumor versus normal tissue delineation, will result in more precise tumor targeting with radiation in an efficient manner and whether there would be fewer toxicities.

Condition or disease
Gynecologic Cancer

Detailed Description:

This study is a clinical research study following patients for toxicity after brachytherapy, and the investigators will be using the D2cc as a surrogate biomarker for determining risk for toxicity in addition to utilizing toxicity measured from physician-queries using the Common Toxicity Criteria for Adverse Events (CTCAE v. 4.0). Patients will have images analyzed for quantification of residual tumor versus fibrosis. The investigators will utilize Magnetic Resonance (MR) tracking, and pilot test: an endovaginal coil, a deflectable Magnetic Resonance stylet, real-time planning software, and auto-segmentation of normal tissues and tumor.

Standard T2-weighted MR images are generally recommended given the soft-tissue visualization without the need for contrast media injection. At the time of brachytherapy, acquisition of para-axial, para-sagittal and para-coronal images should be performed with the orientations being orthogonal (para-axial) and parallel (para-sagittal/para-coronal) to the intrauterine tandem. Slice thickness has a direct impact on applicator reconstruction accuracy, and a slice thickness of ≤3mm is required on the NRG Oncology study (NRG-GY006).

More advanced multi-parametric magnetic resonance imaging (mmpMRI) series show significant promise. A Dynamic Contrast Enhanced (DCE) study identified one voxel cluster consisting of low-enhancing voxels based on the relative signal increase (RSI) time series that was related to locoregional control (adjusted p-value 0.048). Diffusion-weighted (DW)-MRI is used to identify areas of dense residual tumor.31 In one analysis, the mean apparent diffusion coefficient (ADC) value of the primary tumor on pretreatment MRI was an independent predictor of disease-free survival in cervical cancer patients treated with chemoradiation. However, artifacts result in inconsistent contouring at the time of brachytherapy. 3D Slicer is a free open source software application for medical image computing, and will be utilized for some aspects of research in MR Simulator Suite.

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Magnetic Resonance-Guided Brachytherapy Innovations in Gynecologic Cancer-Methods to Identify Remnant Tumor Versus Scar Tissue in Relation to Radiation Therapy
Estimated Study Start Date : June 2022
Estimated Primary Completion Date : June 2027
Estimated Study Completion Date : December 2028
Groups and Cohorts
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Group/Cohort
MR Group
Following standard MRI-guided Brachytherapy, patients will have images analyzed for quantification of residual tumor versus fibrosis. We will pilot-test an endovaginal coil, a deflectable MR stylet, real-time planning software, and auto-segmentation of normal and tumor tissue.


Outcome Measures
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Primary Outcome Measures :
  1. Toxicity rates calculated for patients enrolled on this study [ Time Frame: Up to 24 months post treatment ]
    Toxicity rates will be calculated using the Common Terminology Criteria for Adverse Events (CTCAE v. 4.0)


Secondary Outcome Measures :
  1. Change in tumor as assessed by MRI [ Time Frame: Prior to treatment/at diagnosis and post-brachytherapy treatment up to 14 days ]
    Compare changes in tumor based on MRI.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women with gynecological cancer.
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with gynecological cancer, ages 18 and older.
Criteria

Inclusion Criteria:

Participants must meet the following criteria on screening examination to be eligible to participate in the study:

  • Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the Sidney Kimmel Comprehensive Cancer Center (SKCCC) at Johns Hopkins.
  • Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:

Carcinoma of the cervix: Stage I-IVA or vaginal recurrence Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence Carcinoma of the vagina: Stage I-IVA or vaginal recurrence Carcinoma of the vulva: Stage I-IVA or recurrence Carcinoma of the urethra based on treating physician's discretion

  • Patients who have received prior radiation or chemotherapy may be enrolled on this study.
  • Age > 18 years. Children do not develop these malignancies and therefore are not considered candidates for this trial.
  • Life expectancy of greater than 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance scale. ECOG status of <2, based on treating physician's discretion
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Absolute neutrophil count < 500 at the time of brachytherapy
  • A history of metal in the head or eyes
Contacts and Locations
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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): NCT04530019


Contacts
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Contact: Dana Kaplin, MPH 443-690-7007 dkaplin1@jhmi.edu

Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Investigators
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Study Chair: Akila Viswanathan, MD Johns Hopkins, School of Medicine, Radiation Oncology
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT04530019    
Other Study ID Numbers: IRB00244401
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022

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