RAS Wild TypePhase 1NCT03275974
Glutamine PET Imaging Colorectal Cancer
A Phase 1 study testing Carbon C 11 Glutamine, Fluorine F 18 L-glutamate Derivative BAY94-9392 and Positron Emission Tomography in people with RAS Wild Type and Stage IV Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The clinical trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed tomography (CT) scanning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- RAS Wild Type, Stage IV Colorectal Cancer, Stage IVA Colorectal Cancer
- What is being tested?
- Carbon C 11 Glutamine, Fluorine F 18 L-glutamate Derivative BAY94-9392 and Positron Emission Tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 23 Dec 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
- ≥18 years of age;
- Pathologically or cytologically confirmed diagnosis of metastatic (Stage IV) RAS wildtype CRC;
- Eligible for anti-EGFR monoclonal antibody (mAb) therapy as standard-of-care (SOC), either as a single agent or in combination with approved SOC therapies or investigational agents as part of IRB-approved clinical trials;
- Archived tissue from the CRC primary tumor in sufficient amounts to allow RNA-seq gene analysis; specimen from metastatic sites are not required but highly preferred;
- Documented results from (or scheduled to undergo) CT or MRI of the chest, abdomen and pelvis as a standard-of-care procedure within 28 days of baseline investigational 11C-Gln PET/CT and 18F-FSPG PET/CT;
- Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1;
- At least one lesion >2 cm in diameter and thus will be measurable according to PET Response Criteria in Solid Tumors (PERCIST) v1.0 to avoid PET partial volume effects;
- Ability to provide written informed consent in accordance with institutional policies.
Who cannot join
- Any other current or previous malignancy within the past 5 years
- Previous EGFR-directed therapy
- Body weight ≥ 400 pounds or body habitus or disability that will not permit the imaging protocol to be performed
- Pregnant or lactating females
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glutamine PET Imaging of Colorectal Cancer
The clinical trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed tomography (CT) scanning.
Read the detailed description
PRIMARY OBJECTIVES:
- To establish and validate a 11C-glutamine (11C-Gln) and fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) PET image guided gene signature to predict response to EGFR-targeted therapy in patients with advanced wild-type RAS colorectal cancer (CRC).
OUTLINE:
Patients receive 11C-glutamine intravenously (IV) and undergo PET imaging over 120 minutes. Beginning 2 hours to 7 days after 11C-glutamine PET, patients receive fluorine F 18 L-glutamate derivative BAY94-9392 IV and also undergo PET imaging over 120 minutes. During each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous blood draws will be performed.
- Conditions
- RAS Wild Type, Stage IV Colorectal Cancer, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer
- Being tested
- Carbon C 11 Glutamine, Fluorine F 18 L-glutamate Derivative BAY94-9392, Positron Emission Tomography, Blood Draw
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbon C 11 GlutamineBiological
Given by IV
Fluorine F 18 L-glutamate Derivative BAY94-9392Biological
Given by IV
Positron Emission TomographyProcedure or surgery
Undergo PET scan
Blood DrawProcedure or surgery
Undergo venous blood draws
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients receive carbon C 11 Glutamine (11C-glutamine) IV and undergo PET imaging over 120 minutes. Beginning 2 hours to 7 days after 11C-glutamine PET, patients receive fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) IV and also undergo PET imaging over 120 minutes. During each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous blood draws will be performed. Receives: Biological: Carbon C 11 Glutamine; Biological: Fluorine F 18 L-glutamate Derivative BAY94-9392; Procedure: Positron Emission Tomography; Procedure: Blood Draw |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pet imaging
Assessed in terms of Standardized Uptake Values (SUVs)
Measured: Baseline prior to treatment with anti-EGFR mAb
Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG
The pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG will be determined using compartmental modeling of PET imaging data. Venous samples will be collected over the course of both 11C-Glutamine and 18F-FSPG scans for use in modeling.
Measured: Baseline prior to treatment with anti-EGFR mAb
Change in tumor size
Change in tumor size will be derived from standard-of-care computed tomography (CT) or magnetic resonance imaging (MRI). The tumor size will be reported as either the long-axis diameter or as tumor volume.
Measured: Baseline prior to treatment with anti-EGFR mAb and every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); through treatment completion, an average of 24 weeks (6 cycles)
Secondary outcomes (3)
Gene expression
Gene expression will be determined using RNA-Seq of archived primary (and if available, metastatic) tissues.
Measured: Prior to treatment with anti-EGFR mAb
Progression free survival
Progression-free survival is defined as the time from start of therapy to disease progression by RECIST criteria or death for any reason.
Measured: every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); Up to 4 years after treatment
Overall survival
Overall survival is defined as the time from start of treatment to death for any reason.
Measured: Up to 4 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2017
- Study start27 Apr 2021
- Primary completion23 Dec 2025
- Study completion23 Dec 2025
Why it stopped: \<75% participation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RAS Wild TypeStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simone Krebs, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03275974
- Sponsor's protocol ID
- 2020-1083
- Other IDs
- NCI-2017-01543
- Status last verified
- Sep 2025
- First submitted
- 30 Aug 2017
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamine PET Imaging of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03275974
- Acronym / sponsor ID
- 2020-1083
- Conditions
- RAS Wild Type, Stage IV Colorectal Cancer, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: \<75% participation
- Enrolment
- 6 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 23 Dec 2025 (actual)
- Study completion
- 23 Dec 2025 (actual)
- First posted
- 8 Sep 2017 (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.
The clinical trial studies how well 11C-glutamine and 18F-FSPG positron emission tomography (PET) imaging works in detecting tumors in patients with metastatic colorectal cancer compared to standard imaging methods such as magnetic resonance imaging (MRI) or computed tomography (CT) scanning.
Detailed description
PRIMARY OBJECTIVES:
- To establish and validate a 11C-glutamine (11C-Gln) and fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) PET image guided gene signature to predict response to EGFR-targeted therapy in patients with advanced wild-type RAS colorectal cancer (CRC).
OUTLINE:
Patients receive 11C-glutamine intravenously (IV) and undergo PET imaging over 120 minutes. Beginning 2 hours to 7 days after 11C-glutamine PET, patients receive fluorine F 18 L-glutamate derivative BAY94-9392 IV and also undergo PET imaging over 120 minutes. During each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous blood draws will be performed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Carbon C 11 Glutamine, Biological: Fluorine F 18 L-glutamate Derivative BAY94-9392, Procedure: Positron Emission Tomography, Procedure: Blood DrawPatients receive carbon C 11 Glutamine (11C-glutamine) IV and undergo PET imaging over 120 minutes. Beginning 2 hours to 7 days after 11C-glutamine PET, patients receive fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) IV and also undergo PET imaging over 120 minutes. During each of the 11C-Glutamine and 18F-FSPG PET/CT scans, venous blood draws will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥18 years of age;
- Pathologically or cytologically confirmed diagnosis of metastatic (Stage IV) RAS wildtype CRC;
- Eligible for anti-EGFR monoclonal antibody (mAb) therapy as standard-of-care (SOC), either as a single agent or in combination with approved SOC therapies or investigational agents as part of IRB-approved clinical trials;
- Archived tissue from the CRC primary tumor in sufficient amounts to allow RNA-seq gene analysis; specimen from metastatic sites are not required but highly preferred;
- Documented results from (or scheduled to undergo) CT or MRI of the chest, abdomen and pelvis as a standard-of-care procedure within 28 days of baseline investigational 11C-Gln PET/CT and 18F-FSPG PET/CT;
Key exclusion criteria (4 listed)
- Any other current or previous malignancy within the past 5 years
- Previous EGFR-directed therapy
- Body weight ≥ 400 pounds or body habitus or disability that will not permit the imaging protocol to be performed
- Pregnant or lactating females
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 |
|---|---|---|
| Carbon C 11 GlutamineGiven by IV | Biological | Treatment |
| Fluorine F 18 L-glutamate Derivative BAY94-9392Given by IV | Biological | Treatment |
| Positron Emission TomographyUndergo PET scan | Procedure or surgery | Treatment |
| Blood DrawUndergo venous blood draws | Procedure or surgery | Treatment |
Primary outcome
Pet imaging
Time frame: Baseline prior to treatment with anti-EGFR mAb
Assessed in terms of Standardized Uptake Values (SUVs)
Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG
Time frame: Baseline prior to treatment with anti-EGFR mAb
The pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG will be determined using compartmental modeling of PET imaging data. Venous samples will be collected over the course of both 11C-Glutamine and 18F-FSPG scans for use in modeling.
Change in tumor size
Time frame: Baseline prior to treatment with anti-EGFR mAb and every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); through treatment completion, an average of 24 weeks (6 cycles)
Change in tumor size will be derived from standard-of-care computed tomography (CT) or magnetic resonance imaging (MRI). The tumor size will be reported as either the long-axis diameter or as tumor volume.
3 secondary outcomes
Gene expression
Time frame: Prior to treatment with anti-EGFR mAb
Progression free survival
Time frame: every 8 weeks while on treatment (after every two (2) cycles of anti-EGFR mAb therapy (each cycle is 4 weeks)); Up to 4 years after treatment
Overall survival
Time frame: Up to 4 years after treatment
Results and safety
The study was stopped early (reason given: \<75% participation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Simone Krebs principal investigator
M.D. Anderson Cancer Center
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 Carbon C 11 Glutamine, Fluorine F 18 L-glutamate Derivative BAY94-9392 and Positron Emission Tomography in people with RAS Wild Type and Stage IV Colorectal Cancer, run by M.D. Anderson Cancer Center 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 8 inclusion and 4 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: stopped early, as of the sponsor's last update on 2 Jan 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 was stopped early (reason given: \<75% participation). Results are not available in the source record.
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?
Pet imaging (time frame: Baseline prior to treatment with anti-EGFR mAb). The study lists 3 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 2 Jan 2026.