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NCT01399658 Clinical Trial

Image-Guided Gynecologic Brachytherapy

Cervical Cancer Clinical Trial

— AMIGO  

Official title:
A Clinical Trial to Evaluate Image-Guided Gynecologic Brachytherapy in the Advanced Multimodality Image-Guided Operating Suite (AMIGO)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01399658
Other study ID # 11-098
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2011
Est. completion date June 2016

Study information
Verified date March 2023
Source Dana-Farber Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 93
Est. completion date June 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Image-guided brachytherapy
MRI-guided application of brachytherapy
Drug:
• 3'-Deoxy-3'-18f-Fluorothymidine
Assessing tumor proliferation in Gynecologic cancer

Locations
Country Name City State
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean Doses Given Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement. Measured while on treatment, up to 2 months.
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