- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01217385
Monitoring and Predicting Chemotherapy Response Using DOSI (ACRIN6691)
Diffuse Optical Spectroscopy Imaging in Monitoring and Predicting Response in Patients With Locally Advanced Breast Cancer Undergoing Chemotherapy Before Surgery
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.
Study Overview
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Irvine, California, United States, 92617
- Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
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New Hampshire
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Lebanon, New Hampshire, United States, 03756-0002
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria
- Pathologically confirmed diagnosis of invasive breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy;
- Tumor size >2cm, measured on imaging or estimated by physical exam;
- No contraindications for primary chemotherapy;
- Planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;
- Age 18 years or older;
- ECOG Performance Status ≤ 2 (Karnofsky ≥ 60%; see Appendix II);
Normal organ and marrow function as follows:
- leukocytes ≥ 3,000/μl;
- absolute neutrophil count ≥ 1,500/μl;
- platelets ≥ 100,000/μl;
- total bilirubin within normal institutional limits;
- AST(SGOT)/ALT(SGPT) ≤ 2.5 times the institutional upper limit of normal;
- creatinine within normal institutional limits; OR
- creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal;
- If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by a pregnancy test as per institutional Standard of Care (SOC), and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;
- Able to understand and willing to sign a written informed consent document and a HIPAA authorization in accordance with institutional guidelines;
Exclusion Criteria
- Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy;
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
- Medically unstable;
- Under age 18;
- Pregnant or nursing;
- Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: DOSI Pre-Surgery
Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.
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Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, tissue oxygen saturation (StO2), and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during neoadjuvant chemotherapy (NAC) treatment.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)
Time Frame: From baseline to mid-therapy
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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).
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From baseline to mid-therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
%Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Progesterone Receptor (PR) Status (Positive, Negative, Unknown )
Time Frame: baseline to mid-therapy
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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. |
baseline to mid-therapy
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Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Oxygen Saturation (St02)
Time Frame: baseline to mid-therapy
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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). |
baseline to mid-therapy
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Estimate the Optimal Cutpoint for %Change in TOI From Baseline to Mid-therapy to Predict pCR
Time Frame: baseline to mid-therapy
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Determine the optimal cutpoint (aka Youden-index) for %Change in TOI ratio (T/N) to maximize sensitivity and specificity in the predication of pCR
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baseline to mid-therapy
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Bruce J. Tromberg, MD, Chao Family Comprehensive Cancer Center
Publications and helpful links
General Publications
- Tromberg BJ, Butler JA, Mankoff DA, et al.: ACRIN 6691 monitoring and predicting breast cancer neoadjuvant chemotherapy response using diffuse optical spectroscopic imaging (DOSI). [Abstract] J Clin Oncol 29 (Suppl 15): A-TPS249, 2011.
- Tromberg BJ, Zhang Z, Leproux A, O'Sullivan TD, Cerussi AE, Carpenter PM, Mehta RS, Roblyer D, Yang W, Paulsen KD, Pogue BW, Jiang S, Kaufman PA, Yodh AG, Chung SH, Schnall M, Snyder BS, Hylton N, Boas DA, Carp SA, Isakoff SJ, Mankoff D; ACRIN 6691 investigators. Predicting Responses to Neoadjuvant Chemotherapy in Breast Cancer: ACRIN 6691 Trial of Diffuse Optical Spectroscopic Imaging. Cancer Res. 2016 Oct 15;76(20):5933-5944. doi: 10.1158/0008-5472.CAN-16-0346. Epub 2016 Aug 15.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CDR0000674337
- U01CA080098 (U.S. NIH Grant/Contract)
- U01CA079778 (U.S. NIH Grant/Contract)
- ACRIN-6691 (Other Identifier: ACRIN Foundation)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
See ACRIN data Sharing Policy:
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI)
IPD Sharing Time Frame
IPD Sharing Access Criteria
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