Status:
COMPLETED
Monitoring and Predicting Chemotherapy Response Using DOSI
Lead Sponsor:
American College of Radiology Imaging Network
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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...
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
June 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2014
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01217385
Start Date
June 1 2011
End Date
October 6 2014
Last Update
January 17 2023
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Irvine, California, United States, 92617
2
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0002