RAS Wild Type, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer, Stage IV Colorectal Cancer
Conditions
Brief 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.
Detailed description
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.
Interventions
BIOLOGICALCarbon C 11 Glutamine
Given by IV
Given by IV
PROCEDUREPositron Emission Tomography
Undergo PET scan
PROCEDUREBlood Draw
Undergo venous blood draws
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ≥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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pet imaging | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gene expression | Prior to treatment with anti-EGFR mAb | Gene expression will be determined using RNA-Seq of archived primary (and if available, metastatic) tissues. |
| Progression free survival | 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 | Progression-free survival is defined as the time from start of therapy to disease progression by RECIST criteria or death for any reason. |
| Overall survival | Up to 4 years after treatment | Overall survival is defined as the time from start of treatment to death for any reason. |
Countries
United States
Outcome results
None listed