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NCT01399658 · REGISTRY CONDITION SEARCH

Image-Guided Gynecologic Brachytherapy

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
COMPLETED
Registry last update
2023-03-14

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Mean Doses Given

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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
healthy Volunteers
false
minimum Age
18 Years
sex
FEMALE
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Image-guided brachytherapy
    intervention Names
    1. Procedure: Image-guided brachytherapy
    2. Drug: 3'-Deoxy-3'-18f-Fluorothymidine
    label
    Image-Guided Brachytherapy
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Image-Guided Brachytherapy
    description
    MRI-guided application of brachytherapy
    name
    Image-guided brachytherapy
    other Names
    1. internal radiation therapy
    2. implant radiation
    type
    PROCEDURE
  2. arm Group Labels
    1. Image-Guided Brachytherapy
    description
    Assessing tumor proliferation in Gynecologic cancer
    name
    3'-Deoxy-3'-18f-Fluorothymidine
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
93
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.
    measure
    Mean Doses Given
    time Frame
    Measured while on treatment, up to 2 months.
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
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      query cond
      Vulvar Cancer
      query disease state id
      ds-vulvar-cancer
      source file
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      query disease state id
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      source file
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    Preserved source evidence · Not medical advice