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NCT02419807 · ClinicalTrials.gov registry record · NA
Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer
A NA study, sponsored by Case Comprehensive Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
NCT02419807 is a NA study that has completed, run by Case Comprehensive Cancer Center. The registered enrollment target is 102 participants.
The verdict
NCT02419807, a NA study, has completed, sponsored by Case Comprehensive Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
Study Summary
This clinical trial will enroll up to 130 adult women with a confirmed diagnosis of clinical stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or mastectomy and planned axillary sentinel node biopsy procedure. Participants will undergo lymphatic mapping with technetium Tc-99m (99mTc) sulfur colloid in accordance with routine clinical practice. Injections of 99mTc sulfur colloid will take place the afternoon prior to planned next morning surgery or on the morning of surgery. Participants will undergo lymphoscintigraphy in accordance with standard clinical practice. Immediately prior to operation, after the induction of anesthesia in the operating room, up to 1cc of 0.5% indocyanine green (ICG) solution will be injected subdermally close to the tumor or into the subareolar region after disinfection of the breast skin. ICG movement will be facilitated by manual massage and monitored with fluorescence imaging. ICG fluorescence will be elicited and detected by Photodynamic Eye (PDE) camera. The lymphatic drainage, made evident by the fluorescent dye, will be monitored in real time on a monitor. The fluorescence will be followed towards the armpit region (axilla) and time for the fluorescence to reach the axilla will be recorded. Following standard practice, an incision will be made in the armpit region. Fluorescent lymph nodes (ICG positive) will be localized and removed and analyzed by a pathologist. Node removal will continue until no residual fluorescence is visible in the axilla. Removed nodes will be tested for radioactivity using a standard gamma-detecting probe and the counts per minute will be recorded. Finally, the armpit region will be inspected with the gamma probe to determine if there are any residual radioactive nodes. Residual sentinel nodes (the first node to receive lymph from a tumor) will be removed. For the purposes of this study, the sentinel status of a node will be defined as being flagged as sentinel by either on
Interventions
- PROCEDURE Lymphoscintigraphy
- DRUG Indocyanine Green Solution
- RADIATION Technetium Tc-99m Sulfur Colloid
- PROCEDURE Axillary Lymph Node Biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2015-02-17 |
| Est. Completion | 2019-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02419807
The ClinicalTrials.gov registry entry for NCT02419807 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 102 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Case Comprehensive Cancer Center, which has 407 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Lymphoscintigraphy is the first listed.
NCT02419807 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02419807 about?
NCT02419807 is a clinical study titled "Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer". This clinical trial will enroll up to 130 adult women with a confirmed diagnosis of clinical stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or mastectomy and planned axillary sentinel node biopsy procedure. Participants will undergo lymphatic mapping with technet...
What is the current status of trial NCT02419807?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2015-02-17. Estimated completion is 2019-02.
What interventions are being tested in trial NCT02419807?
The interventions under investigation include: Lymphoscintigraphy (PROCEDURE), Indocyanine Green Solution (DRUG), Technetium Tc-99m Sulfur Colloid (RADIATION), Axillary Lymph Node Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02419807?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
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