PET/CT Evaluation of Treatment Response in Breast Cancer

Vanderbilt University Medical Center

Status: Terminated

Conditions: Breast Cancer

Treatments: Radiation: Radiopharmaceutical: [18F]-FLT; Radiation: Radiopharmaceutical Administration [18F]-FDG

Study type: Interventional

Funder types: Other

Identifiers

NCT01222416

VICC BRE 09108

Details and patient eligibility

About

The purpose of this study is to develop Positron Emission Tomography (PET) - Computed Tomography (CT) PET/CT imaging methods for looking at the effects of chemotherapy in breast cancer.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Subjects must have histologically proven breast cancer
• Subjects are being considered for preoperative chemotherapy
• Subjects must be ≥ 18 years old. Sensor Sub-Study Only
• Palpable subcutaneous or known disease with one surface <1cm below surface of skin.
• A subset of patients who have a mass located on any surface of the breast that is accessible for Lucerno sensor placement will have additional testing.

Exclusion Criteria

• Children will be excluded from this study.
• Pregnant women and women who are breast feeding will be excluded from this study. (The Vanderbilt University Medical Center radiology "PET Procedure Screening Form" will be used to identify and exclude subjects who are pregnant or breastfeeding. A urine pregnancy test/or serum beta HCG will also be performed for women of child bearing potential).
• Patients who are acutely ill who are deemed by their treating physician as not suitable candidates for this study.
• Intraluminal lesions will be excluded from the sensor sub-study.
• Non biopsy proven malignancy will be excluded from this study.
• Palpable subcutaneous or known disease with one surface >1cm below surface of skin will be excluded from the sensor sub-study.
• Draining or exposed malignant tumor will be excluded from the sensor sub-study.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

50 participants in 2 patient groups

fluorodeoxyglucose PET/CT (FDG-PET/CT)

Experimental group

Description:

A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.

Treatment:

Radiation: Radiopharmaceutical Administration [18F]-FDG

fluorodeoxythymidine PET/CT (FLT-PET/CT)

Experimental group

Description:

A PET/CT scan prior to the initiation of therapy, and then two additional scans following the initiation of therapy. Each patient will have up to three scans in a 6 month time frame.

Treatment:

Radiation: Radiopharmaceutical: [18F]-FLT