Image-Guided Gynecologic Brachytherapy (AMIGO)

Dana-Farber Cancer Institute

Status and phase

Completed

Phase 2

Conditions

Uterine Cancer

Vaginal Cancer

Carcinoma of the Vulva

Cervical Cancer

Treatments

Drug: 3'-Deoxy-3'-18f-Fluorothymidine

Procedure: Image-guided brachytherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT01399658

11-098

Details and patient eligibility

About

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.

Full 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.

Enrollment

93 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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