Glutamine PET Imaging Colorectal Cancer

Phase 1TerminatedNCT03275974

M.D. Anderson Cancer Center6 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

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

Interventions

Carbon C 11 GlutamineBIOLOGICAL

Given by IV

Fluorine F 18 L-glutamate Derivative BAY94-9392BIOLOGICAL

Given by IV

Positron Emission TomographyPROCEDURE

Undergo PET scan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Outcomes

Primary Outcomes

Pet imaging

Assessed in terms of Standardized Uptake Values (SUVs)

Time frame: 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.

Time frame: 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.

Time frame: 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)

Secondary Outcomes

Gene expression

Gene expression will be determined using RNA-Seq of archived primary (and if available, metastatic) tissues.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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