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NCT02802553 · ClinicalTrials.gov registry record · NA
Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions
A NA study of Invasive Breast Cancer, sponsored by Case Comprehensive Cancer Center.
- Active
- Registry status
- NA
- Development phase
- 2
- Enrollment target
- 1
- Study location
NCT02802553: Active NA study of Invasive Breast Cancer, sponsored by Case Comprehensive Cancer Center.
NCT02802553 is a NA study of Invasive Breast Cancer that is active but no longer recruiting, run by Case Comprehensive Cancer Center. The registered enrollment target is 2 participants, below the 132-participant average among 19 other Invasive Breast Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02802553, a NA study of Invasive Breast Cancer, is active but no longer recruiting, sponsored by Case Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.
Primary Outcome
Agreement on 6 consecutive participants would occur less than 2% of the time by random chance (p = 0.56 = 0.016). If the two methods agree on all 6 participants, the current protocol will end successfully. However, if the two methods fail to agree on the SLN once among the first 6 participants, enrollment will continue to 25 participants or until a second failed agreement occurs.
Conditions Studied
Interventions
- DEVICE Smart Goggle
- OTHER Cardio-Green
- DEVICE SPY Elite Imaging system
- DEVICE Quest near-infrared (NIR) Imaging system
- DEVICE PDE Imaging system
Study Locations (1)
Ohio
- Cleveland Clinic, Case Comprehensive Cancer Center - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2017-12-28 |
| Est. Completion | 2024-12 |
| Phase | NA |
What the registry record for NCT02802553 still lists
NCT02802553 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 132-participant average among 19 other Invasive Breast Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Invasive Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Smart Goggle is the first listed.
NCT02802553 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02802553 about?
NCT02802553 is a clinical study titled "Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions". This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph...
What is the current status of trial NCT02802553?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 2 participants. The study started on 2017-12-28. Estimated completion is 2024-12.
What conditions does trial NCT02802553 study?
This clinical trial studies the following conditions: Invasive Breast Cancer.
What interventions are being tested in trial NCT02802553?
The interventions under investigation include: Smart Goggle (DEVICE), Cardio-Green (OTHER), SPY Elite Imaging system (DEVICE), Quest near-infrared (NIR) Imaging system (DEVICE), PDE Imaging system (DEVICE).
Who is sponsoring clinical trial NCT02802553?
This trial is sponsored by Case Comprehensive Cancer Center, which has 407 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02802553 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02802553's enrollment target sits among peer trials
2 20th of 19 the lowest of 19 other Invasive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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