RecruitingPhase 1NCT05556473

F-Tryptophan PET/CT in Human Cancers

A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers

Sponsor

Barbara Ann Karmanos Cancer Institute

Enrollment

24 participants

Start Date

Sep 29, 2022

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Rectal Cancer Neuroendocrine Tumors Intracranial Glioma Metastatic Brain Tumor

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria15

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.
\- 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.
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.
Clinical and radiological diagnosis of a breast cancer
ECOG performance status of 2 or better.
Histologically confirmed colorectal cancer, which is located in the rectum.
ECOG performance status of 2 or better.

Exclusion Criteria8

Patients who are pregnant or lactating are excluded.
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
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.
Recent (within 1 month) tumor resection or radio-chemotherapy (acute/subacute post-treatment inflammatory changes may cause false positive increases on PET).
Active inflammatory bowel disease (Crohn's or Ulcerative colitis) involving the rectum.