NCT05556473 · Barbara Ann Karmanos Cancer Institute
F-Tryptophan PET/CT in Human Cancers
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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. Inclusion Criteria specific for Rectal tumors:
- Histologically confirmed colorectal cancer, which is located in the rectum.
- 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). Exclusion Criteria for Rectal tumors: -Active inflammatory bowel disease (Crohn's or Ulcerative colitis) involving the rectum.
Where
- Detroit, Michigan
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 23, 2026 · Source of record for eligibility and locations