TAMU-UT Southwestern Partnership for Breast Imaging and Spectroscopy at 7 Tesla

Study ID
STU 062015-068

Study Sites

  • Clements University Hospital

Contact
Jeannie Baxter
214/645-2726
JEANNIE.BAXTER@UTSouthwestern.edu

Principal Investigator
Craig Malloy, M.D.

Summary

Patients will be referred from the uT Southwestern Breast Clinic after having a standard of care radiologic procedure revealing one or more breast masses that require further follow-up. Patients will be offered participation in this study prior to a standard of care breast biopsy, as 7T MR cannot be done after any metal has been left in the body. normal control subjects will be recruited from other aiRC studies or recruited via flyers.

Patients and normal control subjects will be initially pre-screened either by phone or by face to face meeting. Prescreening will include: MR screening, Pre-enrollment form, and medical/surgical history. after pre-screening, all subjects will either be given a hard copy or email copy of the iCF and HiPaa authorization to review prior to the study visit.

at the study visit, after the consent and HiPaa authorization are explained and obtained, volunteers will be interviewed to determine final eligibility (MR Screening, Pre-enrollment form, and medical/surgical history). Volunteers will be asked to participate either in a 7T breast MRi alone; or a 75g oral or 25g iV glucose tolerance test procedure simultaneously with a 7T breast MRi; or a two hour 24g [u-13C] glucose infusion study followed by a 7T breast MRi.

Patients will participate in only one study procedure so they may quickly continue with standard of care follow-up for their breast mass. normal subjects may enroll in the study for more than one study procedure. The type of study procedure visit for each subject or patient will be randomly assigned depending on what 7T breast coil technology development is available for clinical research application. all subjects will receive $100 by university check for completing either 1) a 7T MRi/MRS alone, or 2) a 7T MRi/MRS simultaneous with oral or iV glucose, or 3) a tracer infusion followed by 7T MRi/MRS.

aim 1:
- oral glucose solution with 2 hours of blood draws
- or iV glucose administration with 2 hours of blood draws
- or no glucose, no blood draws
- plus, all above with simultaneous 7T breast MRi.

aim 2:
- [u-13C] glucose iV bolus and 2 hour infusion with 2 hours of blood draws followed by 7T breast MRi
- or 7T breast MRi, no infusion, no blood draws.

Participant Eligibility

- Female.
- Any age
- Normal control or subject with breast mass/masses identified by ultrasound.
- In good health, as evidenced by medical history and no signs or symptoms of illness.
- Body weight <137 kg. (300lbs.), due to limited size of 7T MR scanner bore.
- Willing to participate under the conditions described in the ICF.
- Able to sign the ICF and applicable HIPAA forms.
- Must be willing to undergo screening for MR procedures.
- Women of child-bearing potential and men must agree to use adequate contraception (hormonal
or barrier method of birth control; abstinence) prior to study entry, for the duration of study
participation. Should a woman become pregnant
or suspect she is pregnant while participating in this study, she should inform her treating
physician immediately.
- A female of child-bearing potential is any woman (regardless of sexual orientation, having
undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:

* Has not undergone a hysterectomy or bilateral oophorectomy; or

* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had
menses at any time in the preceding 12 consecutive months).
- Ability to understand and the willingness to sign a written informed consent.