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NCT01796041 · ClinicalTrials.gov registry record · Early Phase 1
Intraoperative Imaging of Breast Cancer With Indocyanine Green
A Early Phase 1 study of Invasive Ductal Carcinoma and Ductal Carcinoma, sponsored by Abramson Cancer Center at Penn Medicine.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT01796041: Completed Early Phase 1 study of Invasive Ductal Carcinoma and Ductal Carcinoma, sponsored by Abramson Cancer Center at Penn Medicine.
NCT01796041 is a Early Phase 1 study of Invasive Ductal Carcinoma and Ductal Carcinoma that has completed, run by Abramson Cancer Center at Penn Medicine. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01796041, a Early Phase 1 study of Invasive Ductal Carcinoma and Ductal Carcinoma, has completed, sponsored by Abramson Cancer Center at Penn Medicine.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study Summary
According to the World Health Organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000 women perished from the disease in 2002. Surgery remains the best option for patients presenting with operable Stage I, II or III cancers. Breast conservation surgery has been shown to be as efficacious as mastectomy. About 60-70% of these women with operable breast cancer are breast conservation candidates. However, the need to achieve negative tumor margins often requires a second operation (re-excision) in up to 70% of the women having lumpectomy surgery. Currently, tumor margins assessment in the operating room is often assessed grossly by palpation. The ability to evaluate tumor margin using our proposed intraoperative imaging technique may provide the surgeon with an alternative, and hopefully, more sensitive method to assess tumor margins which may decrease re-excision and the morbidity associated with additional surgery, and, perhaps, lower the risk of local regional recurrence.
Primary Outcome
The primary outcome will be the proportion of patient's tumors identified by ICG uptake versus the proportion of patients identified by visual and tactile methods by the surgeon (considered standard of care)
Conditions Studied
Interventions
- DRUG Indocyanine Green
Study Locations (1)
Pennsylvania
- Hospital of the University of Pennsylvania - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-07 |
| Est. Completion | 2016-11-09 |
| Phase | Early Phase 1 |
What the finished NCT01796041 record still lists
NCT01796041 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 3 conditions, with Invasive Ductal Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which Indocyanine Green is the first listed.
NCT01796041 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT01796041 about?
NCT01796041 is a clinical study titled "Intraoperative Imaging of Breast Cancer With Indocyanine Green". According to the World Health Organization, breast cancer is the most common cancer in women, and is responsible for 686,000 new cases every year. The WHO also posit that nearly 420,000 women perished from the disease in 2002. Surgery remains the best option for patients presenting with operable Sta...
What is the current status of trial NCT01796041?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2011-07. Estimated completion is 2016-11-09.
What conditions does trial NCT01796041 study?
This clinical trial studies the following conditions: Invasive Ductal Carcinoma, Ductal Carcinoma, Invasive Lobular Carcinoma.
What interventions are being tested in trial NCT01796041?
The interventions under investigation include: Indocyanine Green (DRUG).
Who is sponsoring clinical trial NCT01796041?
This trial is sponsored by Abramson Cancer Center at Penn Medicine, which has 402 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01796041 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Source ClinicalTrials.gov registry export · 2026-08-08
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