Intracranial GliomaPhase 1NCT05556473
F-Tryptophan PET/CT in Human Cancers
A Phase 1 study testing 1-(2-[18F]FLUOROETHYL)-L-Tryptophan in people with Intracranial Glioma and Metastatic Brain Tumor, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Glioma, Metastatic Brain Tumor, Breast Cancer
- What is being tested?
- 1-(2-[18F]FLUOROETHYL)-L-Tryptophan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2022to 18 Jul 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- 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.
- Histologically confirmed colorectal cancer, which is located in the rectum.
- ECOG performance status of 2 or better.
Who cannot join
- 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
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers
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.
Read the detailed description
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.
- Conditions
- Intracranial Glioma, Metastatic Brain Tumor, Breast Cancer, Neuroendocrine Tumors, Rectal Cancer
- Being tested
- 1-(2-[18F]FLUOROETHYL)-L-Tryptophan
- Medical subject headings
- Brain Neoplasms, Breast Neoplasms, Neuroendocrine Tumors, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1-(2-[18F]FLUOROETHYL)-L-TryptophanDrug
Also called [18F]FETrp PET radiotracer
Radioactive tracer 1-(2-[18F]FLUOROETHYL)-L-Tryptophan 0.14mCi/kg/5MBq/kg injection given one time prior to PET Scan.
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: Drug: 1-(2-[18F]FLUOROETHYL)-L-Tryptophan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During procedure (from right after tracer injection to 1-hour post-injection)
Secondary outcomes (2)
Radiation doses to the various organs.
Radiation doses received by the various organs (heart, lungs, pancreas, gallbladder, liver, small intestines, kidneys, muscle, bladder, ovaries/testes) will be measured from the dynamic 1-(2-[18F]fluoroethyl)-L-tryptophan PET/CT images. Mean and standard deviation of the radiation doses will be calculated for each organ.
Measured: During procedure (from right after tracer injection to 1-hour post-injection)
Overall radiation dose to the study participants.
Overall radiation dose received by the study participants from the PET/CT scan will be calculated from the dynamic 1-(2-[18F]fluoroethyl)-L-tryptophan PET/CT images. Mean and standard deviation of the overall radiation dose will be calculated.
Measured: During procedure (from right after tracer injection to 1-hour post-injection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2022
- Study start29 Sep 2022
- Primary completion18 Jul 2025
- Study completion18 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial GliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Washington University School of Medicine
- Responsible party
- Principal investigator, Csaba Juhasz, Barbara Ann Karmanos Cancer Institute
- Investigators
- Csaba Juhasz, M.D.,Ph.D, Principal investigator, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05556473
- Sponsor's protocol ID
- 2022-010
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2022
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 1-(2-[18f]Fluoroethyl)-L-Tryptophan PET/CT Imaging In Human Cancers
- ClinicalTrials.gov ID
- NCT05556473
- Acronym / sponsor ID
- 2022-010
- Conditions
- Intracranial Glioma, Metastatic Brain Tumor, Breast Cancer, Neuroendocrine Tumors, Rectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- Washington University School of Medicine
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 18 Jul 2025 (actual)
- First posted
- 27 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]FETrp PET radiotracer | Experimental | Drug: 1-(2-[18F]FLUOROETHYL)-L-TryptophanAll participants will receive the tracer to evaluate the uptake of [18F]FETrp PET/CT on intra- and extracranial cancers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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. .
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1-(2-[18F]FLUOROETHYL)-L-TryptophanAlso: [18F]FETrp PET radiotracerRadioactive tracer 1-(2-[18F]FLUOROETHYL)-L-Tryptophan 0.14mCi/kg/5MBq/kg injection given one time prior to PET Scan. | Drug | [18F]FETrp PET radiotracer |
Primary outcome
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)
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.
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)
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.
2 secondary outcomes
Radiation doses to the various organs.
Time frame: During procedure (from right after tracer injection to 1-hour post-injection)
Overall radiation dose to the study participants.
Time frame: During procedure (from right after tracer injection to 1-hour post-injection)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Csaba Juhasz, M.D.,Ph.D principal investigator
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 1-(2-[18F]FLUOROETHYL)-L-Tryptophan in people with Intracranial Glioma and Metastatic Brain Tumor, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.