Monitoring and Predicting Chemotherapy Response Using DOSI

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: DOSI

• Registration Number: NCT01217385
• Lead Sponsor: American College of Radiology Imaging Network

Brief 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.

Detailed Description

OBJECTIVES:

Primary

* To determine whether the percentage change in the diffuse optical spectroscopy imaging (DOSI) measurement of the tumor/normal (T/N) tissue optical index (TOI) from baseline to mid-therapy is predictive of the final pathologic response of the primary tumor in patients with locally advanced breast cancer treated with neoadjuvant chemotherapy.

Secondary

* To investigate whether change of TOI measurements from baseline to post-therapy are predictive of the final pathologic response in these patients treated with this regimen.

* To investigate whether baseline TOI measurements are associated with final pathologic response in patients treated with this regimen.

* To investigate whether TOI measurements at baseline, change from baseline to mid-therapy, and change from baseline to post-therapy correlate with available MRI volumetric imaging measurements.

* To investigate whether changes on TOI measurements from baseline to mid-therapy, and from baseline to post-therapy, correlate with other standard-of-care imaging and/or any MRI-imaging measurements.

* To explore whether additional optical endpoints and indices obtained during DOSI measurements can be used to predict final pathologic response in patients treated with this regimen.

* To determine a cutpoint for the percent change of TOI from baseline to mid-therapy that is predictive of pathological complete response in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients undergo diffuse optical spectroscopy imaging (DOSI) at baseline, 5-10 days after initiation of neoadjuvant chemotherapy, during early- and mid-neoadjuvant therapy, and within 21 days after completion of neoadjuvant therapy. Results are compared to standard-of-care imaging (e.g., MRI, ultrasound, mammography). Patients then undergo surgery.

Study Timeline

• Study First Submitted: 2010-10-07
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-08
• Study Start: 2011-06
• Primary Completion: 2013-06
• Study Completion: 2014-10-06
• Results First Submitted: 2017-06-27
• Results First Submitted QC: 2019-07-02
• Results First Posted: 2019-07-23
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DOSI Pre-Surgery	DOSI	Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.

Primary Outcome Measures

Name	Time	Method
Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)	From baseline to mid-therapy	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).

Secondary Outcome Measures

Name	Time	Method
%Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Progesterone Receptor (PR) Status (Positive, Negative, Unknown )	baseline to mid-therapy	Pathologic Complete response vs Non-Complete response, by PR status Progesterone Receptor Status (positive, negative, unknown ) is determined at pathological assessment of the tumor sample.; %change in TOI is evaluated from baseline to mid-therapy.
Estimate the Optimal Cutpoint for %Change in TOI From Baseline to Mid-therapy to Predict pCR	baseline to mid-therapy	Determine the optimal cutpoint (aka Youden-index) for %Change in TOI ratio (T/N) to maximize sensitivity and specificity in the predication of pCR
Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Oxygen Saturation (St02)	baseline to mid-therapy	subset analysis, subjects were stratified using the median tumor StO2; %change TOI Between Baseline and Mid-therapy dichotomized at -40% stratified by the set evaluable subjects with baseline tumor StO2 dichotomized at 76.9%. (i.e. population median).; Accuracy will be determined using ROC analysis to determine the ROC Area Under the Curve (AUC).

Trial Locations

Locations (2)

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center; 🇺🇸 Irvine, California, United States