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NCT01217385 · ClinicalTrials.gov registry record · NA

Monitoring and Predicting Chemotherapy Response Using DOSI

A NA study, sponsored by American College of Radiology Imaging Network.

Completed
Registry status
NA
Development phase
60
Enrollment target

NCT01217385: Completed NA study, sponsored by American College of Radiology Imaging Network.

NCT01217385 is a NA study that has completed, run by American College of Radiology Imaging Network. The registered enrollment target is 60 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01217385, a NA study, has completed, sponsored by American College of Radiology Imaging Network.

COMPLETED
Registry status
NA
Development phase
60 participants
Enrollment target

Study Summary

RATIONALE: New imaging procedures, such as diffuse optical spectroscopy imaging, may help measure a patient's response and allow doctors to plan better treatment. PURPOSE: This clinical trial studies diffuse optical spectroscopy imaging in monitoring and predicting response in patients with locally advanced breast cancer undergoing chemotherapy before surgery.

Primary Outcome

This measure will look at the Accuracy of % change in DOSI measured Tumor Optical Index (TOI) from baseline to mid therapy to predict pathologic response (pCR+ v pCR-) Pathologic response (dichotomized into responders (pCR+) and non-responders (pCR-) based pathologic assessment) will be used as the reference standard and Accuracy will be determined using receiver operating characteristic (ROC) analysis to determine the ROC Area Under the Curve (AUC).

Interventions

  • PROCEDURE DOSI

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2011-06
Est. Completion 2014-10-06
Phase NA

What the finished NCT01217385 record still lists

NCT01217385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 1 intervention - of which DOSI is the first listed.

NCT01217385 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01217385 about?

NCT01217385 is a clinical study titled "Monitoring and Predicting Chemotherapy Response Using DOSI". RATIONALE: New imaging procedures, such as diffuse optical spectroscopy imaging, may help measure a patient's response and allow doctors to plan better treatment. PURPOSE: This clinical trial studies diffuse optical spectroscopy imaging in monitoring and predicting response in patients with locally...

What is the current status of trial NCT01217385?

This trial is currently completed. It is a NA study. The enrollment target is 60 participants. The study started on 2011-06. Estimated completion is 2014-10-06.

What interventions are being tested in trial NCT01217385?

The interventions under investigation include: DOSI (PROCEDURE).

Who is sponsoring clinical trial NCT01217385?

This trial is sponsored by American College of Radiology Imaging Network, which has 14 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01217385's enrollment target sits among peer trials

60 1164th of 2000 higher than 745 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 NCT01217385, the US trial registry maintained by the National Library of Medicine. NCT01217385 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.