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NCT01401855 · ClinicalTrials.gov registry record
Use of an In Vivo Optical Probe to Discriminate Benign From Malignant Thyroid Nodules
A clinical trial, sponsored by Boston Medical Center.
- Completed
- Registry status
- 300
- Enrollment target
NCT01401855: Completed study, sponsored by Boston Medical Center.
NCT01401855 is a clinical trial that has completed, run by Boston Medical Center. The registered enrollment target is 300 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01401855 has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- 300 participants
- Enrollment target
Study Summary
This study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen. This is the next step in the research that this team has conducted through our prior Institutional Review Board (IRB)H-28135, in which the investigators successfully demonstrated that use of the optical probe readings on thyroid specimens ex vivo could successfully discriminate benign from malignant disease. The Elastic Scattering Spectroscopy (ESS) probe has also been IRB approved and a clinical trial conducted in vivo at Boston University/Boston Medical Center by Dr. Satish Singh and Dr. Irving Bigio. The investigators intend to now bring this project to the clinical setting of thyroid disease. The optical real-time readings will be compared to the histological analysis from the same area. Subjects already undergoing thyroid biopsy for thyroid disease including thyroid nodules, thyroid cancer and thyroid goiter with nodules will be eligible to participate. During the already scheduled thyroid procedure using a fine needle aspiration biopsy needle, optical readings will be taken from the thyroid gland and these same areas will then be analyzed in the usual standard fashion. The reading will then be correlated with the histological results. In addition, if lymph nodes are biopsied as part of the evaluation they will also be tested prior to histological standard processing. All specimens and data will be de-identified once data collection and analysis is complete. Our goal is to use optical real-time readings to improve the differential diagnosis of benign from malignant thyroid nodules and avoid surgery for the purpose of diagnosis alone.
Primary Outcome
The objective is to assess a device called an optical probe for the differentiation of thyroid cancer from normal thyroid tissue, benign thyroid nodules or parathyroid glands, and the detection of thyroid cancer within lymph nodes. The gold standard for diagnosis is ultrasound guided fine needle aspiration biopsy of the nodule. Based on cytology from Fine Needle Aspiration (FNA), 10% of nodules are cancer, 70% are benign (not cancer) and 20% are "indeterminate." The proposed device aims to decre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2011-06 |
| Est. Completion | 2014-06 |
What the finished NCT01401855 record still lists
NCT01401855 is an observational study that tracks outcomes without assigning an intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01401855 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01401855 about?
NCT01401855 is a clinical study titled "Use of an In Vivo Optical Probe to Discriminate Benign From Malignant Thyroid Nodules". This study will investigate the usefulness of an optical probe in the differentiation of thyroid cancer from normal thyroid tissue in a thyroidectomy specimen. This is the next step in the research that this team has conducted through our prior Institutional Review Board (IRB)H-28135, in which the i...
What is the current status of trial NCT01401855?
This trial is currently completed. The enrollment target is 300 participants. The study started on 2011-06. Estimated completion is 2014-06.
Who is sponsoring clinical trial NCT01401855?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
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