Image-Guided Gynecologic Brachytherapy

Phase 2

Completed

• Conditions: Carcinoma of the Vulva; Cervical Cancer; Vaginal Cancer; Uterine Cancer
• Interventions: Procedure: Image-guided brachytherapy; Drug: 3'-Deoxy-3'-18f-Fluorothymidine

• Registration Number: NCT01399658
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

Standard therapy for gynecologic cancers involves the use of brachytherapy, also called internal radiation therapy or implant radiation. The treatment being studied consists of standard brachytherapy with the additional use of MRI to guide the insertion of radioactive applicators. The purpose of the study is to find out whether MRI-guided brachytherapy is practical and beneficial when compared to the standard CT-guided brachytherapy placement. The investigators are hoping that this MRI procedure will decrease the risk of giving too high a radiation dose to the bladder or bowel.

Detailed Description

The insertion of the brachytherapy applicator will be administered in the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. Subjects will undergo an MRI scan in the AMIGO suite ensuring proper placement of the applicator. Subjects may have an optional FMISO-PET scan.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 90 days after treatment.

Subjects will have a follow-up visit including physical exam, pap smear, and MRI of the pelvis and/or PET scan 180 days after treatment.

Study Timeline

• Study First Submitted: 2011-07-08
• Study First Submitted QC: 2011-07-20
• Study First Posted: 2011-07-22
• Study Start: 2011-09
• Primary Completion: 2016-02
• Study Completion: 2016-06
• Results First Submitted: 2022-02-08
• Results First Submitted QC: 2022-02-08
• Results First Posted: 2022-03-02
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 93

Inclusion Criteria

• Histologically or cytologically confirmed carcinoma of the cervix (Stage I-IVA), carcinoma of the uterus (Stage IIIB), carcinoma of the vagina (Stage I-IVA), or carcinoma of the vulva (stage I-IVA)
• Life expectancy > 6 months
• MRI of the pelvis and/or PET-CT within 4 months prior to entering study

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Exclusion Criteria

• Uncontrolled intercurrent illness
• Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Image-Guided Brachytherapy	3'-Deoxy-3'-18f-Fluorothymidine	Image-guided brachytherapy
Image-Guided Brachytherapy	Image-guided brachytherapy	Image-guided brachytherapy

Primary Outcome Measures

Name	Time	Method
Mean Doses Given	Measured while on treatment, up to 2 months.	Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States