Brachytherapy Innovations in Gynecologic Cancer

NCT04530019 | Withdrawn DMC

• 1 other identifier: IRB00244401
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gynecologic Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity rates calculated for patients enrolled on this study

  Toxicity rates will be calculated using the Common Terminology Criteria for Adverse Events (CTCAE v. 4.0)

  Up to 24 months post treatment

Secondary Outcomes (1)

• Change in tumor as assessed by MRI

  Prior to treatment/at diagnosis and post-brachytherapy treatment up to 14 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women with gynecological cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with gynecological cancer, ages 18 and older.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead

Study Officials

• Akila Viswanathan, MD

  Johns Hopkins, School of Medicine, Radiation Oncology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: October 1, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032
• Last Updated: November 29, 2024

Record last verified: 2024-11