Overview

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).