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F-Tryptophan PET/CT in Human Cancers

RecruitingPhase 1

A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers

Who can join

Ages 18 and older · All sexes

Full 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.

About the study

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.

What is being tested

Sponsor: Barbara Ann Karmanos Cancer Institute · Participants: 24 · Started: Sep 29, 2022

Contact the study team

Official record on ClinicalTrials.gov — NCT05556473

Locations in the U.S.

MichiganKarmanos Cancer Institute, Detroit

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.