Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments systemic chemotherapy, laser spectroscopy, breast imaging study, magnetic resonance imaging, mammography, neoadjuvant therapy, therapeutic conventional surgery, ultrasound imaging
Phase phase 1/phase 2
Sponsor American College of Radiology Imaging Network
Collaborator National Cancer Institute (NCI)
Start date March 2011
End date June 2013
Trial size 60 participants
Trial identifier NCT01217385, ACRIN-6691, CA80098, CDR0000674337

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.
systemic chemotherapy
laser spectroscopy
breast imaging study
magnetic resonance imaging
mammography
neoadjuvant therapy
therapeutic conventional surgery
ultrasound imaging

Primary Outcomes

Measure
Relationship between pathological complete response and percent change from baseline to post-therapy in tissue optical index (TOI) tumor to normal ratio
time frame: Until surgery

Secondary Outcomes

Measure
Relationship between pathological complete response and baseline TOI tumor to normal ratio (CR+PR vs none and CR vs non-CR)
time frame: Until surgery
Relationship between pathological complete response and percent change from baseline to early-therapy in TOI tumor to normal ratio (CR+PR vs none and CR vs non-CR)
time frame: Until surgery
Correlation between the TOI measurement and any MR volumetric imaging measurements
time frame: Until surgery
Relationship between pathological complete response and other optical endpoints and indices (CR+PR vs none and CR vs non-CR)
time frame: Until surgery
Cutpoint that maximizes the sensitivity and specificity for the percent change of TOI from baseline to mid-therapy, where the positive reference standard is pathological complete response
time frame: Until surgery

Eligibility Criteria

Female participants at least 18 years old.

DISEASE CHARACTERISTICS: - Diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy (confirmed by the local site pathologist) - Locally advanced disease - Planned primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant chemotherapy - No contraindications for primary chemotherapy - Tumor size ≥ 2 cm by imaging or estimated by physical exam - Hormone receptor status not specified PATIENT CHARACTERISTICS: - Menopausal status not specified - ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% - WBC ≥ 3,000/μL - ANC ≥ 1,500/μL - Platelet count ≥ 100,000/μL - Total bilirubin normal - AST and ALT ≤ 2.5 times upper limit of normal (ULN) - Creatinine normal OR creatinine clearance ≥ 30 mL/min - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No uncontrolled intercurrent illness including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness and/or social situations that would limit compliance with study requirements - Not medically unstable - At least 5 years since prior malignancy except basal cell or squamous cell carcinoma of the skin, or in situ carcinoma of the cervix PRIOR CONCURRENT THERAPY: - See Disease Characteristics - No prior chemotherapy, radiotherapy, or surgery to involved breast, including hormone therapy

Additional Information

Official title Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI)
Principal investigator Bruce J. Tromberg, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2013.
Information provided to ClinicalTrials.gov by American College of Radiology Imaging Network.