Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
6 participants
INTERVENTIONAL
2021-04-27
2025-12-23
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Treatment
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.
Carbon C 11 Glutamine
Given by IV
Fluorine F 18 L-glutamate Derivative BAY94-9392
Given by IV
Positron Emission Tomography
Undergo PET scan
Blood Draw
Undergo venous blood draws
Interventions
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Carbon C 11 Glutamine
Given by IV
Fluorine F 18 L-glutamate Derivative BAY94-9392
Given by IV
Positron Emission Tomography
Undergo PET scan
Blood Draw
Undergo venous blood draws
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Simone Krebs
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2017-01543
Identifier Type: OTHER
Identifier Source: secondary_id
2020-1083
Identifier Type: -
Identifier Source: org_study_id
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