An Imaging Agent ([18F]FETrp) with Positron Emission Tomography/Computed Tomography for Visualizing Brain, Breast, and Neuroendocrine Tumors

Inclusion Criteria

• Age >= 18 years
• Targeted lesion (tumor) is at least 1 cm in diameter as shown by clinical imaging
• Patient is able to lie in the PET/CT scanner for at least 70 minutes while undergoing scanning
• Women of childbearing potential must not be pregnant or breastfeeding. A negative urine or blood pregnancy test must be obtained in women with childbearing potential within 7 days prior to the PET scan
• Recent anatomic imaging with visible disease (tumor) for comparison with the PET/CT. This could be done within 4 weeks for brain, rectal and breast cancer and within 8 weeks for neuroendocrine tumors
• Physical exam within 28 days of PET imaging, complete blood count (CBC) and multiphasic (including electrolytes, blood urea nitrogen [BUN], creatinine, total bilirubin, aspartate aminotransferase [AST], and alanine aminotransferase [ALT]) done within 14 days of PET imaging. Eligibility is not restricted by these results
• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study
• INTRACRANIAL TUMORS: Clinical and magnetic resonance imaging (MRI) diagnosis of an intracranial lesion suspicious for a brain tumor, including gliomas or metastatic brain tumors; primary, residual, or recurrent brain tumors (judged by clinical imaging) will qualify
• NEUROENDOCRINE TUMORS: Histopathologically confirmed, well-differentiated metastatic neuroendocrine tumor
• NEUROENDOCRINE TUMORS: Eastern Cooperative Oncology Group (ECOG) performance status of 2 or better
• NEUROENDOCRINE TUMORS: Patients receiving stable-dose somatostatin analogs (SSAs, long-acting release [LAR], depot) for > 3 months before enrollment may be enrolled on the study, but such treatment is not required
• PRIMARY BREAST CANCERS: Clinical and radiological diagnosis of a breast cancer (including nonmetastatic breast cancer about to undergo upfront surgery or neoadjuvant [preoperative] chemotherapy, as well as metastatic breast cancer, prior to first line chemotherapy). Also patients with previously diagnosed and treated breast cancer, who are now progressing, prior to starting a new line of therapy
• PRIMARY BREAST CANCERS: ECOG performance status of 2 or better
• RECTAL CANCERS: Histologically confirmed colorectal cancer, which is located in the rectum
• RECTAL CANCERS: ECOG performance status of 2 or better

Exclusion Criteria

• Patients who are pregnant or lactating are excluded. Premenopausal women must have a negative pregnancy test (urine or serum) within 7 days of PET. Men and women with reproductive potential should employ appropriate contraception
• INTRACRANIAL TUMORS: Severe increased intracranial pressure, status epilepticus, or other symptoms requiring emergency or urgent intervention
• INTRACRANIAL TUMORS: Tumor surgery or radiation within 1 month prior to the PET scan (acute/subacute post-treatment inflammatory changes may cause false positive increases on PET)
• NEUROENDOCRINE TUMORS: Tumor-directed therapy within 3 months to the area of planned imaging. If the patients have had liver-directed therapy within 3 months, they must have an area outside the liver to be imaged
• NEUROENDOCRINE TUMORS: Ongoing treatment with a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide)
• NEUROENDOCRINE TUMORS: Use of telotristat ethyl (a tryptophan-hydroxylase inhibitor) within one month
• PRIMARY BREAST CANCERS: Recent (within 1 month) tumor resection or radio-chemotherapy (acute/subacute post-treatment inflammatory changes may cause false positive increases on PET)
• RECTAL CANCERS: Active inflammatory bowel disease (Crohn’s or Ulcerative colitis) involving the rectum