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Glutamine PET Imaging Colorectal Cancer

Primary Purpose

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

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Carbon C 11 Glutamine

Fluorine F 18 L-glutamate Derivative BAY94-9392

Positron Emission Tomography

Blood Draw

About this trial

This is an interventional diagnostic trial for RAS Wild Type

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

M D Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

Pet imaging

Assessed in terms of Standardized Uptake Values (SUVs)

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.

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.

Secondary Outcome Measures

Gene expression

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

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.

Overall survival

Overall survival is defined as the time from start of treatment to death for any reason.

Full Information

NCT ID

NCT03275974

First Posted

August 30, 2017

Last Updated

October 13, 2023

Sponsor

M.D. Anderson Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT03275974

Brief Title

Glutamine PET Imaging Colorectal Cancer

Official Title

Glutamine PET Imaging of Colorectal Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 27, 2021 (Actual)

Primary Completion Date

November 30, 2024 (Anticipated)

Study Completion Date

November 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

Carbon C 11 Glutamine

Intervention Description

Given by IV

Intervention Type

Biological

Intervention Name(s)

Fluorine F 18 L-glutamate Derivative BAY94-9392

Intervention Description

Given by IV

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography

Intervention Description

Undergo PET scan

Intervention Type

Procedure

Intervention Name(s)

Blood Draw

Intervention Description

Undergo venous blood draws

Primary Outcome Measure Information:

Title

Pet imaging

Description

Assessed in terms of Standardized Uptake Values (SUVs)

Time Frame

Baseline prior to treatment with anti-EGFR mAb

Title

Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG

Description

Time Frame

Baseline prior to treatment with anti-EGFR mAb

Title

Change in tumor size

Description

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 Outcome Measure Information:

Title

Gene expression

Description

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

Title

Progression free survival

Description

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

Title

Overall survival

Description

Overall survival is defined as the time from start of treatment to death for any reason.

Time Frame

Up to 4 years after treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Allison Cohen

Phone

(713) 794-4324

ascohen1@mdanderson.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lesley Flynt

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

M D Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Allison Cohen

Phone

713-794-4324

ascohen1@mdanderson.org

First Name & Middle Initial & Last Name & Degree

Lesley Flynt

12. IPD Sharing Statement

Links:

URL

http://mdanderson.org

Description

MD Anderson Cancer Center

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Glutamine PET Imaging Colorectal Cancer

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