F-Tryptophan PET/CT in Human Cancers

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.
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  • - 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05556473
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Barbara Ann Karmanos Cancer Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Csaba Juhasz, M.D.,Ph.D
Principal Investigator Affiliation Barbara Ann Karmanos Cancer Institute
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Intracranial Glioma, Metastatic Brain Tumor, Breast Cancer, Neuroendocrine Tumors, Rectal Cancer
Additional Details

In this research study, we will compare the uptake of the tracer on F-Tryp PET/CT in patients with cancers; specifically, to evaluate whether the tumors show increased tracer uptake as compared to non-tumor tissues, using F-Tryp PET/CT. Additionally, we will evaluate the biodistribution (i.e. track where the tracer has traveled in the body) and radiation dosimetry (i.e., absorbed dose of tracer in tissue). These changes may be compared with results of the physical examination and scans (CT and MRI or standard clinical PET) that are done as part of routine clinical care or as part of other studies. Pictures (images) from the PET scan will be made showing the distribution throughout the body of substances containing a small amount of radioactive material.

Arms & Interventions

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

Drug: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Karmanos Cancer Institute, Detroit, Michigan

Status

Recruiting

Address

Karmanos Cancer Institute

Detroit, Michigan, 48201

Site Contact

Csaba Juhasz, MD, PhD

[email protected]

313-966-5136

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