Improved Method of Detecting Cancer Metastases
SITs
Study of Instillation Technique Using The Modified Intra- Uterine Manipulator Catheter With Methylene Blue, Isosulfan Blue or Indocyanine Green Dyes, Compared to Cervical Injection, For Sentinel Lymph Node Detection in Endometrial Carcinoma
1 other identifier
interventional
30
1 country
1
Brief Summary
The purpose of this study is to compare the Instillation Technique Using The Modified Intra- Uterine Manipulator Catheter With Methylene Blue, Isosulfan Blue or Indocyanine Green Dyes, Compared to Cervical Injection, For Sentinel Lymph Node Detection in Endometrial Carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedFebruary 20, 2015
February 1, 2015
1 year
November 17, 2014
February 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of sentinel nodes detected by each method.
To determine if the new procedure is better than the current method of sentinal node detection. We will determine which dye and which route is most sensitive for detected metastatic cancer. Each Sentinel node dye and route will be compared to the full node dissection result.
1 Year
Secondary Outcomes (2)
Time to detection of 1st SN by each method.
1 year
Sensitivity of each method compared to full node dissection.
1 year
Study Arms (2)
Standard of Care Sentinal Node Dye
ACTIVE COMPARATORSurgery route, as determined by the patient and clinician, will determine which standard clinical dye will be used.
Installation of Study Sentinal Node Dye
EXPERIMENTALSurgery route, as determined by the patient and clinician, will determine which study dye will be used for delivery by the experimental route.
Interventions
Delivery of sentinal node dye by different routes
Patients will receive different types of dye by different routes of administration
Eligibility Criteria
You may qualify if:
- Age: ≥ 18 years old at the time of consent.
- Preoperatively diagnosed endometrial carcinoma of any stage or grade and planned to undergo surgery (laparotomy, laparoscopy or robotic assisted) at IUSCC.
- Medically operable status.
- Ability to understand and willingness to sign a written informed consent and authorization for the release of health information.
You may not qualify if:
- Previous radiotherapy.
- Previous retroperitoneal surgery.
- Significant physical limitations preventing proper vaginal examination as determined by the treating physician.
- Personal history of allergy to iodides, iodine or shellfish.
- No clinical indication for intra-uterine manipulator use.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southeastern Regional Medical Center
Newnan, Georgia, 30265, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Giuseppe Del Priore, MD
Southeastern Regional Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2014
First Posted
February 20, 2015
Study Start
June 1, 2014
Primary Completion
June 1, 2015
Study Completion
December 1, 2015
Last Updated
February 20, 2015
Record last verified: 2015-02