RECRUITING

F-Tryptophan PET/CT in Human Cancers

Conditions

Intracranial Glioma Metastatic Brain Tumor Breast Cancer Neuroendocrine Tumors Rectal Cancer

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-09-29

Study Completion:2024-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05556473

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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. * 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.	* 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.

Inclusion Criteria

Exclusion 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.
* 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.

* 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.

Contacts and Locations

Study Contact

Csaba Juhasz, M.D., Ph.D

CONTACT

313-966-5136

csaba.juhasz@wayne.edu

Principal Investigator

Csaba Juhasz, M.D.,Ph.D

PRINCIPAL_INVESTIGATOR

Barbara Ann Karmanos Cancer Institute

Study Locations (Sites)

Karmanos Cancer Institute

Detroit, Michigan, 48201

United States

Collaborators and Investigators

Sponsor: Barbara Ann Karmanos Cancer Institute

Csaba Juhasz, M.D.,Ph.D, PRINCIPAL_INVESTIGATOR, Barbara Ann Karmanos Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-09-29

Study Completion Date2024-12-31

Study Record Updates

Study Start Date2022-09-29

Study Completion Date2024-12-31

Terms related to this study

Additional Relevant MeSH Terms

Intracranial Glioma
Metastatic Brain Tumor
Breast Cancer
Neuroendocrine Tumors
Rectal Cancer