MDACC Study Summary 2006-0501

Study Summary
No. 2006-0501:.......Breast......Gary Whitman......Diagnostic Radiology

Study Summary Title



Study Summary Number:	2006-0501

Study Title:	Non-invasive MRI and MRS Techniques for Assessing Therapeutic Response to Pre-surgical Chemotherapy in Breast Cancer Patients

Physician

New Patient Referral



Name:	Gary Whitman	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Diagnostic Radiology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3520 Contact us about clinical trials

General Information



Disease Group:	Breast	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	For each patient, three MRI/MRS studies will be performed on both breasts including the symptomatic breast before, 21 ą 3 days after initial chemotherapy (day 1 = first day of chemotherapy), at the end of the chemotherapy and prior to any surgery.

Treatment Agents:	5-Fluorouracil AD5CMV-P53 Capecitabine Cyclophosphamide Docetaxel Epirubicin Paclitaxel Trastuzumab	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to learn if magnetic resonance imaging (MRI) with magnetic resonance spectroscopy (MRS) can show the effects of pre-surgical chemotherapy in breast cancer patients who are eligible to receive preoperative chemotherapy.

Study Objectives / Outcomes

The overall goal of this proposed pilot study is to validate, based on tissue-based measures, quantitative measures of tissue function obtained non-invasively by dynamic contrast enhanced (DCE) MRI, diffusion-weighted (DW) MRI, and proton MR spectroscopy (1H MRS) techniques for assessing the effects of pre-surgical chemotherapy in breast cancer patients who are eligible to receive preoperative chemotherapy.
The specific aims of this project are: (1) to incorporate DCE-MRI, DW-MRI, and MRS techniques and analysis tools into the clinical MRI exam to determine longitudinal changes in permeability, cellularity and metabolism in breast tumors of breast cancer patients undergoing pre-surgical chemotherapy; and (2) to compare quantitative MR measurements from patients with histopathological and immunohistochemical (IHC) findings from mastectomy and segmental mastectomy specimens.

Study Status Information



Study Activation / Registration Date:	10/25/2006

IRB Review and Approval Date:	07/19/2006

Study Type:	Other

Recruitment Status:	Open

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with newly diagnosed stage II A-B or III A-C breast cancers who are scheduled to start systemic chemotherapy.

2) Patients must have a histological diagnosis of invasive breast cancer.

3) Patients whose extent of disease is determined by physical examination and conventional imaging (mammography and sonography).

4) Patients should have not received any previous chemotherapy for their newly diagnosed Stage II A-B or III A-C breast cancer.

5) Patients must be age 18 or older.

6) ECOG performance status 0-2.

7) Patients with history of prior malignancies must be disease-free for at least 5 years prior of study entry.

8) Normal hematological function: WBC > 3000/ul, absolute neutrophil count > 1500/ul, platelets > 100,000/ul, and Hgb > 10 gms (transfusion to achieve Hgb > 10 gms is acceptable).

9) Serum total bilirubin < 1.5 mg/dl and SGPT < 1.5 X normal.

10) Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policies of the hospital. The only acceptable consent form is the one attached at the end of this protocol.

Exclusion Criteria:

1) Patients who received previous chemotherapy for the newly diagnosed breast cancer.

2) Patients with no evidence of primary breast lesion (e.g., T0, Tx).

3) Patients who are unwilling to come back for regular assessments of response.

4) Patients with claustrophobia or obesity (exceeding the equipment weight limits).

5) Pregnant women, lactating women or sexually active women of childbearing potential who are not practicing adequate contraception.

6) Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmias.

7) Patients with pacemakers or other metallic inserts that are not compatible with 3-T MR scanners.

8) Patients with bilateral breast disease, and recurrent newly diagnosed breast cancer.

Links

Registration Number: NCT00490503
Study Information on Clinical Trials Registry (clinicaltrials.gov)