F-Tryptophan PET/CT in Human Cancers

NCT05556473 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 2022-010
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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; Breast Cancer; Metastatic Brain Tumor; Neuroendocrine Tumors; Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• The percent difference in tracer uptake values between the tumor mass and the background (non-tumor tissue)

  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.

  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.

  The 1-(2-\[18F\]fluoroethyl)-L-tryptophan tracer standardized uptake values and the volume of distribution (characterizing the tracer transport rates) will be measured by PET/CT imaging in the same breast tumor tissues, and the correlation of these two measures will be calculated.

  During procedure (from right after tracer injection to 1-hour post-injection)

Secondary Outcomes (2)

• Radiation doses to the various organs.

  During procedure (from right after tracer injection to 1-hour post-injection)

• Overall radiation dose to the study participants.

  During procedure (from right after tracer injection to 1-hour post-injection)

Study Arms (1)

[18F]FETrp PET radiotracer

EXPERIMENTAL

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

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

Interventions

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

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

Also known as: [18F]FETrp PET radiotracer

[18F]FETrp PET radiotracer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \- 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.
• 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.
• Clinical and radiological diagnosis of a breast cancer
• ECOG performance status of 2 or better.
• Histologically confirmed colorectal cancer, which is located in the rectum.
• ECOG performance status of 2 or better.

You may not qualify if:

• Patients who are pregnant or lactating are excluded.
• 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
• 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.
• Recent (within 1 month) tumor resection or radio-chemotherapy (acute/subacute post-treatment inflammatory changes may cause false positive increases on PET).
• Active inflammatory bowel disease (Crohn's or Ulcerative colitis) involving the rectum.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• Washington University School of Medicine: collaborator

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms; Breast Neoplasms; Neuroendocrine Tumors; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Csaba Juhasz, M.D.,Ph.D

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Csaba Juhasz, M.D., Ph.D

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: September 29, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)