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Monitoring and Predicting Chemotherapy Response Using DOSI (ACRIN6691)

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

DOSI

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DOSI Pre-Surgery

Arm Description

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

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.

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

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).

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

Determine the optimal cutpoint (aka Youden-index) for %Change in TOI ratio (T/N) to maximize sensitivity and specificity in the predication of pCR

Full Information

NCT ID

NCT01217385

First Posted

October 7, 2010

Last Updated

January 12, 2023

Sponsor

American College of Radiology Imaging Network

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01217385

Brief Title

Monitoring and Predicting Chemotherapy Response Using DOSI

Acronym

ACRIN6691

Official Title

Diffuse Optical Spectroscopy Imaging in Monitoring and Predicting Response in Patients With Locally Advanced Breast Cancer Undergoing Chemotherapy Before Surgery

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

June 2011 (Actual)

Primary Completion Date

June 2013 (Actual)

Study Completion Date

October 6, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

American College of Radiology Imaging Network

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DOSI Pre-Surgery

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

DOSI

Other Intervention Name(s)

Diffuse Optical Spectroscopic Imaging, Laser spectroscopy, Optical Breast Imaging

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

From baseline to mid-therapy

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

baseline to mid-therapy

Title

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

Description

Time Frame

baseline to mid-therapy

Title

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

Description

Determine the optimal cutpoint (aka Youden-index) for %Change in TOI ratio (T/N) to maximize sensitivity and specificity in the predication of pCR

Time Frame

baseline to mid-therapy

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce J. Tromberg, MD

Organizational Affiliation

Chao Family Comprehensive Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Irvine

State/Province

California

ZIP/Postal Code

92617

Country

United States

Facility Name

Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center

City

Lebanon

State/Province

New Hampshire

ZIP/Postal Code

03756-0002

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing 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

after publication of Primary manuscript

IPD Sharing Access Criteria

See ACRIN data sharing policy

IPD Sharing URL

https://www.acrin.org/RESEARCHERS/POLICIES/DATAANDIMAGESHARINGPOLICY.aspx

Citations:

Citation

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.

Results Reference

result

PubMed Identifier

27527559

Citation

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.

Results Reference

result

Links:

URL

https://clinicaltrials.gov/ct2/show/NCT01217385

Description

National Cancer Institute's clinical trials database

URL

http://www.acrin.org/6691_protocol.aspx

Description

For additional information about the ACRIN 6691 trial, visit the ACRIN Web site.

Learn more about this trial

Monitoring and Predicting Chemotherapy Response Using DOSI

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