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NCT00734955 · ClinicalTrials.gov registry record · NA

An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients

A NA study, sponsored by Duke University.

Completed
Registry status
NA
Development phase
485
Enrollment target

NCT00734955: Completed NA study, sponsored by Duke University.

NCT00734955 is a NA study that has completed, run by Duke University. The registered enrollment target is 485 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00734955, a NA study, has completed, sponsored by Duke University.

COMPLETED
Registry status
NA
Development phase
485 participants
Enrollment target

Study Summary

Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also shown that data collection and processing from a single point on the tissue specimen requires less than 5 seconds. In addition, the technique is easily adaptable to provide sensing depths that are required for breast margin assessment. The goal of the work proposed in this protocol is to test the sensitivity and specificity of an optical assay system developed by our group, for intra operative assessment of breast tumor margins.

Primary Outcome

The primary outcome measure of this study is to identify the optical signatures of normal and cancerous tissue.

Interventions

  • DEVICE 49-channel optical spectrometer

Trial Details

FieldValue
Enrollment Target 485 participants
Start Date 2006-05
Est. Completion 2017-07
Phase NA
Duke University

1,725 total trials

What the finished NCT00734955 record still lists

NCT00734955 is an interventional study that assigns participants to a tested intervention. The registered 485 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (65% lower).

The record links to 0 conditions, and to 1 intervention - of which 49-channel optical spectrometer is the first listed.

NCT00734955 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00734955 about?

NCT00734955 is a clinical study titled "An Optical Assay System for Intra Operative Assessment of Tumor Margins in Patients". Our objective is to develop a novel optical assay system for intra operative assessment of tumor margins in partial mastectomy or mastectomy specimens. Our group has previously shown that optical techniques can effectively discriminate between malignant and non-malignant breast tissues. We have also...

What is the current status of trial NCT00734955?

This trial is currently completed. It is a NA study. The enrollment target is 485 participants. The study started on 2006-05. Estimated completion is 2017-07.

What interventions are being tested in trial NCT00734955?

The interventions under investigation include: 49-channel optical spectrometer (DEVICE).

Who is sponsoring clinical trial NCT00734955?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00734955's enrollment target sits among peer trials

485 216th of 2000 higher than 1,785 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT00734955, the US trial registry maintained by the National Library of Medicine. NCT00734955 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.