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 currently recruiting participants.
Verified February 2013 by American College of Radiology Imaging Network
Sponsor:
American College of Radiology Imaging Network
Collaborator:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT01217385
First received: October 7, 2010
Last updated: February 1, 2013
Last verified: February 2013
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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 |
| Estimated Primary Completion Date: | October 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
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 | Recruiting |
| Irvine, California, United States, 92617 | |
| Contact: Bruce J. Tromberg, MD 949-824-7545 | |
| United States, New Hampshire | |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Recruiting |
| Lebanon, New Hampshire, United States, 03756-0002 | |
| Contact: Peter A. Kaufman, MD 603-650-0328 peter.a.kaufman@hitchcock.org | |
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:
No publications provided
| 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: | February 1, 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 May 21, 2013