NCT05556473 F-Tryptophan PET/CT in Human Cancers
| NCT ID | NCT05556473 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Barbara Ann Karmanos Cancer Institute |
| Condition | Intracranial Glioma |
| Study Type | INTERVENTIONAL |
| Enrollment | 24 participants |
| Start Date | 2022-09-29 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 24 participants in total. It began in 2022-09-29 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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. 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.
Contact & Investigator
Csaba Juhasz, M.D.,Ph.D
PRINCIPAL INVESTIGATOR
Barbara Ann Karmanos Cancer Institute
Frequently Asked Questions
Who can join the NCT05556473 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Intracranial Glioma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05556473 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05556473 currently recruiting?
Yes, NCT05556473 is actively recruiting participants. Contact the research team at csaba.juhasz@wayne.edu for enrollment information.
Where is the NCT05556473 trial being conducted?
This trial is being conducted at Detroit, United States.
Who is sponsoring the NCT05556473 clinical trial?
NCT05556473 is sponsored by Barbara Ann Karmanos Cancer Institute. The principal investigator is Csaba Juhasz, M.D.,Ph.D at Barbara Ann Karmanos Cancer Institute. The trial plans to enroll 24 participants.