Using F-Tryptophan PET/CT to Improve Cancer Imaging
A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers
This study is testing a new type of imaging scan to see if it can help doctors better spot and understand different cancers in patients.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barbara Ann Karmanos Cancer Institute Academic / other |
| Drugs / interventions | sunitinib, chemotherapy, radiation |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05556473 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of 1-(2-[18F]FLUOROETHYL)-L-Tryptophan PET/CT imaging in patients with various cancers, including gliomas, metastatic brain tumors, breast cancer, neuroendocrine tumors, and rectal cancer. The goal is to determine if tumors exhibit higher uptake of the tracer compared to non-tumor tissues, which could enhance treatment planning. The study will also assess the biodistribution of the tracer and the radiation dosimetry involved. Patients will undergo PET/CT scans, and results will be compared with standard imaging techniques.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with specific tumors that are at least 1 cm in diameter and have visible disease on recent imaging.
Not a fit: Patients with tumors smaller than 1 cm or those who cannot undergo PET/CT scanning may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate cancer imaging and better treatment strategies for patients.
How similar studies have performed: Other studies using advanced imaging techniques have shown promise, suggesting potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Detroit, Michigan
- Karmanos Cancer Institute — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Csaba Juhasz, M.D.,Ph.D — Barbara Ann Karmanos Cancer Institute
- Study coordinator: Csaba Juhasz, M.D., Ph.D
- Email: csaba.juhasz@wayne.edu
- Phone: 313-966-5136
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.