Imaging of Primary or Recurrent Breast Cancer With 18F-FluorThanatrace Positron Emission Tomography (PET/CT)

832165

Patients with known or suspected, in the opinion of an investigator, primary or metastatic breast cancer may be eligible for this study. Up to 45 evaluable participants may undergo study imaging in this protocol. The imaging procedure may include one or both of the following imaging sessions; 1) a 45- 60 minute dynamic scan, starting at approximately the same time as the injection and/or 2) a skull base to mid-thigh scan starting approximately 60 minutes post injection of \[18F\]FTT. The planned scanning protocol will be selected by an investigator and will be discussed with the participant prior to the imaging visit. The PET/CT scan will include an injection of \[18F\]FTT. Data will be collected to evaluate uptake of \[18F\]FTT in breast cancer and compare with PARP-1 activity in tissue, when available. If participants are getting neoadjuvant or other systemic therapy, a second optional scan may be performed 1 day to 4 weeks after therapy begins to evaluate whether response correlates with increase in PARP-1 activity.

2019-02-11

2026-02-01

2027-02-01

Recruiting

50

Inclusion Criteria: 1. Participants will be ≥ 18 years of age 2. Known or suspected, in the opinion of an investigator, primary breast or metastatic breast cancer. For subjects with primary breast cancer we will target lesion size of 1.0 cm or greater on at least one type of standard imaging. 3. Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures. Exclusion Criteria: 1. Females who are pregnant or breast feeding at the time of enrollment will not be eligible for this study; a urine pregnancy test will be performed in women of child-bearing potential prior to FTT injection. 2. Inability to tolerate imaging procedures in the opinion of an investigator or treating physician 3. Any current medical condition, illness, or disorder as assessed by medical record review and/or self-reported that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Tissue will only be collected for research purpose, if there is adequate tissue available, after the clinical diagnostic needs are met.\n\nIf the participants are undergoing a clinical biopsy for suspected breast cancer, they may be asked to provide additional samples for experimental pathologic evaluations or establishment of cell lines at the time of the clinical biopsy.'}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2024-02-16