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NCT01902953 · ClinicalTrials.gov registry record · Phase 2
Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)
A Phase 2 study, sponsored by Maimonides Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
NCT01902953: Completed Phase 2 study, sponsored by Maimonides Medical Center.
NCT01902953 is a Phase 2 study that has completed, run by Maimonides Medical Center. The registered enrollment target is 16 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01902953, a Phase 2 study, has completed, sponsored by Maimonides Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
Study Summary
45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of colon cancer will be included in this study. During colon operation the affected portion of the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by a pathologist. Analysis of the lymph nodes in the specimen are important because this is an important aspect of determining the stage of the cancer. Once the standard technique is used for the colon removal operation and the specimen is removed it will be injected with two drugs to help identify the lymph nodes. One is a blue dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for the standard pathologic evaluation. The patient themselves will never be injected with these drugs being used for research. Following the standard lymph node evaluation, an additional pathologist at an outside research facility will further examine the lymph nodes in the specimen using more in depth techniques which are above and beyond the standard of care. The results of all the pathologic tests will be conveyed to the surgeon of record to help in their decision making regarding further treatment. The study hypothesis is that radiotracer will be at least as effective as blue dye in identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once identified, these sentinel nodes can then undergo a more in depth review leading to improved staging of colorectal cancer and more accurate treatment.
Primary Outcome
Number of Participants in Concordance of in vivo detection rates of Lymphoseek and VBD in excised lymph nodes as tissue phenotype is confirmed by histology.
Interventions
- DRUG Lymphoseek and VBD Sln dissection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-03 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
What the finished NCT01902953 record still lists
NCT01902953 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 1 intervention - of which Lymphoseek and VBD Sln dissection is the first listed.
NCT01902953 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01902953 about?
NCT01902953 is a clinical study titled "Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)". 45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of colon cancer will be included in this study. During colon operation the affected portion of the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by a pathologist. Analysi...
What is the current status of trial NCT01902953?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2013-03. Estimated completion is 2016-06.
What interventions are being tested in trial NCT01902953?
The interventions under investigation include: Lymphoseek and VBD Sln dissection (DRUG).
Who is sponsoring clinical trial NCT01902953?
This trial is sponsored by Maimonides Medical Center, which has 39 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01902953's enrollment target sits among peer trials
16 1908th of 2000 higher than 82 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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