Glutamine PET Imaging Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    May 31, 2025
  • participants needed
    30
  • sponsor
    M.D. Anderson Cancer Center
Updated on 10 August 2022

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.

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.

Details
Condition RAS Wild Type, Stage IV Colorectal Cancer, Stage IVA Colorectal Cancer, Stage IVB Colorectal Cancer
Treatment positron emission tomography, Blood draw, Carbon C 11 Glutamine, Fluorine F 18 L-glutamate Derivative BAY94-9392
Clinical Study IdentifierNCT03275974
SponsorM.D. Anderson Cancer Center
Last Modified on10 August 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note