Image-Guided Gynecologic Brachytherapy

NCT ID: NCT01399658

Last Updated: 2023-03-14

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2016-06-30

Brief Summary

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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

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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.

Conditions

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Cervical Cancer Uterine Cancer Vaginal Cancer Carcinoma of the Vulva

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Image-Guided Brachytherapy

Image-guided brachytherapy

Group Type EXPERIMENTAL

Image-guided brachytherapy

Intervention Type PROCEDURE

MRI-guided application of brachytherapy

3'-Deoxy-3'-18f-Fluorothymidine

Intervention Type DRUG

Assessing tumor proliferation in Gynecologic cancer

Interventions

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Image-guided brachytherapy

MRI-guided application of brachytherapy

Intervention Type PROCEDURE

3'-Deoxy-3'-18f-Fluorothymidine

Assessing tumor proliferation in Gynecologic cancer

Intervention Type DRUG

Other Intervention Names

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internal radiation therapy implant radiation

Eligibility Criteria

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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

Exclusion Criteria

* Uncontrolled intercurrent illness
* Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Martin King, MD, PhD

Prinicipal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martin King, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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11-098

Identifier Type: -

Identifier Source: org_study_id

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