Clinical trial · Interventional
F-Tryptophan PET/CT in Human Cancers
A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers
NCT05556473CI-TRIAL-00101541recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Intracranial Glioma | — | UNRESOLVED | — |
| Metastatic Brain Tumor | Brain Neoplasm | CURATED_BROADER | 0.78 |
| Neuroendocrine Tumors | Neuroendocrine Tumor | ONTOLOGY_EXACT | 0.90 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 1-(2-[18F]FLUOROETHYL)-L-Tryptophan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- [18F]FETrp PET radiotracer
- description
- All participants will receive the tracer to evaluate the uptake of \[18F\]FETrp PET/CT on intra- and extracranial cancers.
- interventionNames
- Drug: 1-(2-[18F]FLUOROETHYL)-L-Tryptophan
Primary outcomes (2)
- measure
- The percent difference in tracer uptake values between the tumor mass and the background (non-tumor tissue)
- timeFrame
- During procedure (from right after tracer injection to 1-hour post-injection)
- description
- The percent difference in 1-(2-\[18F\]fluoroethyl)-L-tryptophan tracer standardized uptake values, measured between tumor and non-tumor (normal) tissues by PET/CT imaging, in each subject, will be calculated. Mean and standard deviation of the percent differences will be calculated for each tumor type.
- measure
- Correlation between the 1-(2-[18F]fluoroethyl)-L-tryptophan tracer uptake values and the tracer transport rates measured in the same breast tumor tissue.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.