F-Tryptophan PET/CT in Human Cancers
Recruiting · NCT05556473 · Interventional (participants receive a specific treatment) · Lead sponsor: Barbara Ann Karmanos Cancer Institute
View the official record on ClinicalTrials.gov →Interventions studied
1-(2-[18F]FLUOROETHYL)-L-Tryptophan
What this trial 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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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 it is running
2 locations listed across 1 US state.
- Karmanos Cancer Institute - Detroit, Michigan, United States
- Karmanos Cancer Institute - Detroit, Michigan, United States