Recruiting
Phase 1

F-Tryptophan

Sponsor:

Barbara Ann Karmanos Cancer Institute

Code:

NCT05556473

Conditions

Intracranial Glioma

Metastatic Brain Tumor

Breast Cancer

Neuroendocrine Tumors

Rectal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

1-(2-[18F]FLUOROETHYL)-L-Tryptophan

Study Details

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.

Conditions

Intracranial Glioma

Metastatic Brain Tumor

Breast Cancer

Neuroendocrine Tumors

Rectal Cancer

Study ID

NCT05556473

Start date

Sep 29, 2022

Status verified date

Jan, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

24 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: [18F]FETrp PET radiotracer

All participants will receive the tracer to evaluate the uptake of \[18F\]FETrp PET/CT on intra- and extracranial cancers.

Interventions

1-(2-[18F]FLUOROETHYL)-L-Tryptophan

Radioactive tracer 1-(2-\[18F\]FLUOROETHYL)-L-Tryptophan 0.14mCi/kg/5MBq/kg injection given one time prior to PET Scan.

Primary outcome measure

  • The percent difference in tracer uptake values between the tumor mass and the background (non-tumor tissue) [ Time Frame: During procedure (from right after tracer injection to 1-hour post-injection) ]
  • Correlation between the 1-(2-[18F]fluoroethyl)-L-tryptophan tracer uptake values and the tracer transport rates measured in the same breast tumor tissue. [ Time Frame: During procedure (from right after tracer injection to 1-hour post-injection) ]

Central Contacts and Locations

Central contacts

Csaba Juhasz, M.D., Ph.D

313-966-5136csaba.juhasz@wayne.edu

Locations

Karmanos Cancer Institute

Recruiting

Detroit, Michigan, United States, 48201

Contacts

More Information

Sponsor

Barbara Ann Karmanos Cancer Institute

Last update posted

Jan 23, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Barbara Ann Karmanos Cancer Institute on 2026-01-23.