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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-01543 | Other Identifier | NCI-CTRP Clinical Trials Reporting Registry |
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<75% participation
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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.
PRIMARY OBJECTIVES:
I. 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carbon C 11 Glutamine | Biological | Given by IV |
| |
| Fluorine F 18 L-glutamate Derivative BAY94-9392 |
| Measure | Description | Time Frame |
|---|---|---|
| Pet imaging | Assessed in terms of Standardized Uptake Values (SUVs) | 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. | 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Gene expression | Gene expression will be determined using RNA-Seq of archived primary (and if available, metastatic) tissues. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Simone Krebs | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| M D Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Mar 18, 2025 | Dec 29, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D009682 | Magnetic Resonance Spectroscopy |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
| D013048 | Specimen Handling |
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| Biological |
Given by IV |
|
| Positron Emission Tomography | Procedure | Undergo PET scan |
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| Blood Draw | Procedure | Undergo venous blood draws |
|
| 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. | Up to 4 years after treatment |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |