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Glutamine PET Imaging for Colorectal Cancer
Phase 1
Waitlist Available
Led By Lesley Flynt
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
≥18 years of age
Pathologically or cytologically confirmed diagnosis of metastatic (Stage IV) RAS wildtype CRC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years after treatment
Awards & highlights
Study Summary
This trial is testing a new way of imaging tumors in patients with metastatic colorectal cancer, to see if it is more effective than the standard methods.
Who is the study for?
This trial is for adults over 18 with metastatic colorectal cancer that hasn't been treated with EGFR-directed therapy. They must have a tumor sample available, measurable disease by certain criteria, and be eligible for anti-EGFR antibody therapy. It's not for those who are pregnant, lactating, or have had another cancer in the past 5 years.Check my eligibility
What is being tested?
The study tests how well two PET imaging agents (11C-glutamine and 18F-FSPG) detect tumors compared to standard MRI or CT scans in patients with metastatic colorectal cancer. The goal is to see if these new agents offer clearer images of the tumors.See study design
What are the potential side effects?
Potential side effects from the PET imaging process may include discomfort at the injection site, allergic reactions to tracers, and exposure to radiation which carries a risk of cancer though it's very low.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
My colorectal cancer is stage IV and RAS wildtype.
Select...
I am eligible for anti-EGFR therapy as part of my standard cancer treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in tumor size
Pet imaging
Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG
Secondary outcome measures
Gene expression
Overall survival
Progression free survival
Side effects data
From 2022 Phase 2 trial • 46 Patients • NCT024482259%
Dyspnea
9%
Non-cardiac chest pain
2%
Pneumothorax
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
Trial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Draw
2006
Completed Phase 4
~2400
Fluorine F 18 L-glutamate Derivative BAY94-9392
2015
Completed Phase 2
~50
Positron Emission Tomography
2008
Completed Phase 2
~2240
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,796 Total Patients Enrolled
Lesley FlyntPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a tumor larger than 2 cm that can be measured by PET scan.I have received treatment targeting EGFR before.I have enough archived tissue from my primary colorectal cancer for gene analysis.My weight is over 400 pounds or my body shape or disability prevents me from undergoing certain scans.I have not had any other cancer in the last 5 years.I am 18 years old or older.My colorectal cancer is stage IV and RAS wildtype.I have had (or will have) a CT or MRI of my chest, abdomen, and pelvis within the last 28 days.I am eligible for anti-EGFR therapy as part of my standard cancer treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are the known risks associated with Fluorine F 18 L-glutamate Derivative BAY94-9392 to human health?
"Our internal analysis at Power has ascribed a safety rating of 1 to Fluorine F 18 L-glutamate Derivative BAY94-9392 due to the limited data available in Phase 1 trials regarding efficacy and security."
Answered by AI
What is the scope of enrollment for this clinical trial?
"Correct. Clinicaltrials.gov confirms that this investigation, which was posted on May 22nd 2018, is still enrolling patients. Approximately 30 people must be recruited from a solitary medical centre."
Answered by AI
Have researchers explored the efficacy of Fluorine F 18 L-glutamate Derivative BAY94-9392 in other investigations?
"Presently, there are 5 clinical trials in progress for Fluorine F 18 L-glutamate Derivative BAY94-9392 with one of them already at its third phase. 9 different medical centres across New york City are hosting the studies."
Answered by AI
Are there still opportunities available for participants in this clinical experiment?
"Clinicaltrials.gov affirms that this experiment is actively enrolling individuals, with the initial posting on May 22nd 2018 and most recent update on September 22nd 2022."
Answered by AI
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