Monitoring and Predicting Chemotherapy Response Using DOSI

NCT01217385 | Completed Results DMC

• 4 other identifiers: CDR0000674337ACRIN-6691U01CA080098U01CA079778
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

• Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict Pathologic Response (pCR +/-)

  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).

  From baseline to mid-therapy

Secondary Outcomes (3)

• %Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Progesterone Receptor (PR) Status (Positive, Negative, Unknown )

  baseline to mid-therapy

• Accuracy of %Change in TOI Between Baseline and Mid-therapy to Predict pCR+; Stratified by Oxygen Saturation (St02)

  baseline to mid-therapy

• Estimate the Optimal Cutpoint for %Change in TOI From Baseline to Mid-therapy to Predict pCR

  baseline to mid-therapy

Study Arms (1)

DOSI Pre-Surgery

EXPERIMENTAL

Participants undergo approximately four assessments of breast health using the DOSI technology during treatment and prior to surgery for breast cancer.

Procedure: DOSI

Interventions

DOSI PROCEDURE

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.

Also known as: Diffuse Optical Spectroscopic Imaging, Laser spectroscopy, Optical Breast Imaging

DOSI Pre-Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• American College of Radiology Imaging Network: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center

Irvine, California, 92617, United States

Location

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756-0002, United States

Location

Related Publications (2)

• 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.

  RESULT

• 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.

  PMID: 27527559 RESULT

Related Links

• National Cancer Institute's clinical trials database

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Spectrometry, Mass, Matrix-Assisted Laser Desorption-Ionization

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mass Spectrometry; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Donna Hartfeil, Director Protocol Management
• Organization: American College of Radiology

dhartfeil@acr.org

215-717-2765

Study Officials

• Bruce J. Tromberg, MD

  Chao Family Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2010
• First Posted: October 8, 2010
• Study Start: June 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: October 6, 2014
• Last Updated: January 17, 2023
• Results First Posted: July 23, 2019

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: after publication of Primary manuscript
• Access Criteria: See ACRIN data sharing policy

Locations

US (2)