Diffuse Optical Spectroscopy Imaging in Monitoring and Predicting Response in Patients With Locally Advanced Breast Cancer Undergoing Chemotherapy Before Surgery (ACRIN 6691)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01217385
First received: October 7, 2010
Last updated: October 14, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: systemic chemotherapy
Other: laser spectroscopy
Procedure: breast imaging study
Procedure: magnetic resonance imaging
Procedure: mammography
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
Procedure: ultrasound imaging
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging (DOSI)

Resource links provided by NLM:


Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Correlation between the TOI measurement and any MR volumetric imaging measurements [ Time Frame: Until surgery ] [ Designated as safety issue: No ]
  • Relationship between pathological complete response and other optical endpoints and indices (CR+PR vs none and CR vs non-CR) [ Time Frame: Until surgery ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: March 2011
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: systemic chemotherapy Other: laser spectroscopy Procedure: breast imaging study Procedure: magnetic resonance imaging Procedure: mammography Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery Procedure: ultrasound imaging

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01217385

Locations
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Irvine, California, United States, 92617
United States, New Hampshire
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002
Sponsors and Collaborators
American College of Radiology Imaging Network
Investigators
Principal Investigator: Bruce J. Tromberg, MD Chao Family Comprehensive Cancer Center
  More Information

Additional Information:
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.

Responsible Party: American College of Radiology Imaging Network
ClinicalTrials.gov Identifier: NCT01217385     History of Changes
Other Study ID Numbers: CDR0000674337, ACRIN-6691, CA80098
Study First Received: October 7, 2010
Last Updated: October 14, 2013
Health Authority: United States: Federal Government
United States: NCI

Keywords provided by American College of Radiology Imaging Network:
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 20, 2014