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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Uterine Cancer, Vaginal Cancer, Carcinoma of the Vulva

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Trial Information

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


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 FLT-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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Dose determination

Outcome Description:

To determine doses to the rectum, sigmoid and bladder obtained after AMIGO-guided placement compared to standard CT-guided treatment with the anticipation that AMIGO-guided placement will result in lower OAR dosing than standard CT-based imaging.

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Akila N Viswanathan, M.D., M.P.H.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brigham and Women's Hospital

Authority:

United States: Institutional Review Board

Study ID:

11-098

NCT ID:

NCT01399658

Start Date:

September 2011

Completion Date:

Related Keywords:

  • Cervical Cancer
  • Uterine Cancer
  • Vaginal Cancer
  • Carcinoma of the Vulva
  • Brachytherapy
  • Gynecological cancer
  • Carcinoma
  • Uterine Cervical Neoplasms
  • Uterine Neoplasms
  • Vaginal Neoplasms
  • Vulvar Neoplasms

Name

Location

Brigham and Women's HospitalBoston, Massachusetts  02115