Image-Guided Gynecologic Brachytherapy

NCT01399658 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 11-098
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Uterine Cancer; Vaginal Cancer; Carcinoma of the Vulva

Keywords

Brachytherapy; Gynecological cancer

Outcome Measures

Primary Outcomes (1)

• Mean Doses Given

  Doses given to the tumor, rectum, and sigmoid obtained after AMIGO-guided placement.

  Measured while on treatment, up to 2 months.

Study Arms (1)

Image-Guided Brachytherapy

EXPERIMENTAL

Image-guided brachytherapy

Procedure: Image-guided brachytherapy; Drug: 3'-Deoxy-3'-18f-Fluorothymidine

Interventions

Image-guided brachytherapy PROCEDURE

MRI-guided application of brachytherapy

Also known as: internal radiation therapy, implant radiation

Image-Guided Brachytherapy

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

Assessing tumor proliferation in Gynecologic cancer

Image-Guided Brachytherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Uncontrolled intercurrent illness
• Pacemaker, brain aneurysm clip, inner ear implant, neurostimulator, or metal fragments in the eye

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Uterine Neoplasms; Vaginal Neoplasms; Vulvar Neoplasms

Interventions

Brachytherapy; alovudine

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Vaginal Diseases; Vulvar Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics

Results Point of Contact

• Title: Martin King, MD
• Organization: Dana-Farber Cancer Institute

Martin_King@dfci.harvard.edu

617-732-4332

Study Officials

• Martin King, MD, PhD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: July 8, 2011
• First Posted: July 22, 2011
• Study Start: September 1, 2011
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: March 14, 2023
• Results First Posted: March 2, 2022

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)