Clinical Trials /

Glutamine PET Imaging Colorectal Cancer

NCT03275974

Description:

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Glutamine PET Imaging Colorectal Cancer
  • Official Title: Glutamine PET Imaging of Colorectal Cancer

Clinical Trial IDs

  • ORG STUDY ID: VICC GI 1781
  • SECONDARY ID: NCI-2017-01543
  • NCT ID: NCT03275974

Conditions

  • RAS Wild Type
  • Stage IV Colorectal Cancer
  • Stage IVA Colorectal Cancer
  • Stage IVB Colorectal Cancer

Interventions

DrugSynonymsArms
Carbon C 11 GlutamineTreatment
Fluorine F 18 L-glutamate Derivative BAY94-9392Treatment

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
TreatmentExperimentalPatients receive 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 IV and also undergo PET imaging over 120 minutes.

    Eligibility Criteria

            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 irinotecan-containing
                 regimens
    
              -  Archived tissue from the CRC primary tumor in sufficient amounts to allow advanced
                 quantitative real time-polymerase chain reaction (qRT-PCR) 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 SOC 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) version
                 (v)1.1
    
              -  At least one lesion measurable according to PET Response Criteria in Solid Tumors
                 (PERCIST) v1.0: > 2 cm in diameter 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Pet imaging
    Time Frame:Up to 4 years
    Safety Issue:
    Description:Assessed in terms of Standardized Uptake Values (SUVs)

    Secondary Outcome Measures

    Measure:Change in tumor size (e.g., long-axis diameter, tumor volume)
    Time Frame:Up to 24 months
    Safety Issue:
    Description:Change in tumor size will be derived from standard-of-care computed tomography or magnetic resonance imaging
    Measure:Plasma levels of Gln, Glu, cystine, and substrates and metabolites related to glutaminolysis and amino acid transport
    Time Frame:Up to 24 months
    Safety Issue:
    Description:
    Measure:Progression free survival
    Time Frame:Up to 4 years
    Safety Issue:
    Description:
    Measure:Overall survival
    Time Frame:Up to 4 years
    Safety Issue:
    Description:

    Details

    Phase:Early Phase 1
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Vanderbilt-Ingram Cancer Center

    Last Updated

    November 10, 2017