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NCT02287675 · ClinicalTrials.gov registry record · Phase 4
Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer
A Phase 4 study of Breast Cancer, sponsored by Kettering Health Network.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT02287675: Completed Phase 4 study of Breast Cancer, sponsored by Kettering Health Network.
NCT02287675 is a Phase 4 study of Breast Cancer that has completed, run by Kettering Health Network. The registered enrollment target is 40 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02287675, a Phase 4 study of Breast Cancer, has completed, sponsored by Kettering Health Network.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
To compare the kinetics and efficacy of two functionally different diagnostic agents, Lymphoseek (CD206 receptor targeted) and 99mTc-Sulfur Colloid (SC) (Sulfur Colloid non-specific mapping agent) in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).
Primary Outcome
The rate of injection site clearance is the time from radiotracer injection to peak SLN radioactive level. Injection clearance rates will be determined by planar SPECT imaging and by SPECT/CT. Subjects will undergo standard sequential planar imaging at 30 to 60 seconds intervals until the sentinel lymph node is seen. Once a sentinel node is located, a SPECT/CT will be performed for higher resolution imaging in transaxial, coronal, and sagittal planes.
Conditions Studied
Interventions
- DRUG Lymphoseek
- DRUG Sulfur Colloid
Study Locations (1)
Ohio
- Kettering Medical Center - Kettering
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2015-01-19 |
| Est. Completion | 2017-08-31 |
| Phase | Phase 4 |
What the finished NCT02287675 record still lists
NCT02287675 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Lymphoseek is the first listed.
NCT02287675 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT02287675 about?
NCT02287675 is a clinical study titled "Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer". To compare the kinetics and efficacy of two functionally different diagnostic agents, Lymphoseek (CD206 receptor targeted) and 99mTc-Sulfur Colloid (SC) (Sulfur Colloid non-specific mapping agent) in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node Biopsy (SLNB).
What is the current status of trial NCT02287675?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2015-01-19. Estimated completion is 2017-08-31.
What conditions does trial NCT02287675 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT02287675?
The interventions under investigation include: Lymphoseek (DRUG), Sulfur Colloid (DRUG).
Who is sponsoring clinical trial NCT02287675?
This trial is sponsored by Kettering Health Network, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02287675 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 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 NCT02287675's enrollment target sits among peer trials
40 876th of 1224 higher than 325 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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