Role of Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner in Evaluating Neoadjuvant Chemotherapy Response in Patients With Breast Cancer
Status
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Treatments
Details and patient eligibility
About
The purpose of this study is:
- To evaluate the hypothesis: Can PEM Flex Solo II PET scanner ascertain response to neoadjuvant chemotherapy in patients with breast cancer?
- To compare the results from the PEM Flex Solo II PET scanner to the standard of care bilateral breast MRI.
Full description
Subjects will receive bilateral (both sides) breast and axillary PEM scans. All recruited subjects chosen for the study will have biopsy proven breast cancer and are eligible for chemotherapy. They will undergo bilateral breast MRI for staging which is considered standard of care. Breast MRI and PEM scans will be performed at at baseline (phase 0 or pre-operative phase), 2nd MRI and PEM after 1 to 2 weeks of NAC (phase 1) and 3rd MRI and PEM after 1 to 2 weeks of phase 1 (phase 2). DCE-MRI and PEM will be performed not more than 14 days apart within each phase. Cranio-Caudal (CC) and Medial Lateral Oblique (MLO) PEM views will be performed of both the ipsilateral and contralateral breast and axillae by a Mammography Technologist trained in mammographic positioning.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Women 18-75 years old with newly diagnosed breast cancer who are considered candidates for breast conserving surgery (i.e., lumpectomy)
Exclusion criteria
- Children (< 18 years old)
- Pregnant or Lactating women
- Diabetic patients (Type I or II)
- Patients who are scheduled for a sentinel node procedure using radioactive Tc-99m within 24 hours of PEM
- Patients who have NOT undergone a standard of care bilateral breast MRI
Trial design
Primary purpose
Allocation
Interventional model
Masking
5 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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