F-Tryptophan PET/CT in Human Cancers

• Status: Recruiting
• Trial end date: 2024-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Imaging procedures such as 1-(2-[18F]FLUOROETHYL)-L-Tryptophan PET/CT in patients with cancers may help doctors assess a patient's response to treatment and help plan the best treatment in the future. The purpose is to see if there can be a better differentiation of tumor and non-tumor tissue where the tumor tissue has a higher uptake of Tryptophan.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Barbara Ann Karmanos Cancer Institute
• Treatments: Tryptophan

Criteria

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.

• Recent anatomic imaging with visible disease (tumor) for comparison with the PET/CT. .

• Physical exam within 28 days of PET imaging, CBC and Multiphasic (including electrolytes, BUN, creatinine, total bilirubin, AST and ALT) within 14 days.

• Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

Inclusion Criteria Specific for Intracranial Tumors - Clinical and 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.

Inclusion Criteria Specific for Extracranial Neuroendocrine Tumors:

• Histopathologically confirmed, well-differentiated metastatic neuroendocrine tumor.

• ECOG performance status of 2 or better.

• 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.

Inclusion Criteria specific for Extracranial Primary Breast tumors:

• Clinical and radiological diagnosis of a breast cancer

• ECOG performance status of 2 or better.

Exclusion Criteria:

• Patients who are pregnant or lactating are excluded.

Exclusion Criteria Specific for Intracranial Tumors:

• Severe increased intracranial pressure, status epilepticus, or other symptoms requiring emergency or urgent intervention.

• Tumor surgery or radiation within 1 month prior to the PET scan

Exclusion Criteria Specific for Extracranial Neuroendocrine Tumors:

• Tumor-directed therapy within 3 months to the area of planned imaging.

• Ongoing treatment with a targeted agent (e.g., sunitinib or everolimus) or receiving cytotoxic chemotherapy (e.g., capecitabine or temozolomide).

• Use of telotristat ethyl (a tryptophan-hydroxylase inhibitor) within one month.

Exclusion Criteria for Extracranial Primary Breast tumors:

-Recent (within 1 month) tumor resection or radio-chemotherapy (acute/subacute post-treatment inflammatory changes may cause false positive increases on PET).