Fluorine F 18 L-glutamate Derivative BAY94-9392 for Stage IV Colorectal Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stage IV Colorectal Cancer+3 MoreFluorine F 18 L-glutamate Derivative BAY94-9392 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way of imaging tumors in patients with metastatic colorectal cancer, to see if it is more effective than the standard methods.

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 3 Secondary · Reporting Duration: Up to 4 years after treatment

Baseline prior to treatment with anti-EGFR mAb
Pet imaging
Pharmacokinetic rate constants for 11C-Glutamine and 18F-FSPG
Week 24
Change in tumor size
Prior to treatment with anti-EGFR mAb
Gene expression
Year 4
Overall survival
Year 4
Progression free survival

Trial Safety

Side Effects for

Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT)
9%Non-cardiac chest pain
9%Dyspnea
2%Pneumothorax
This histogram enumerates side effects from a completed 2022 Phase 2 trial (NCT02448225) in the Diagnostic (18F-FDG PET/CT, 18F-FSPG PET/CT) ARM group. Side effects include: Non-cardiac chest pain with 9%, Dyspnea with 9%, Pneumothorax with 2%.

Trial Design

1 Treatment Group

Treatment
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Fluorine F 18 L-glutamate Derivative BAY94-9392 · No Placebo Group · Phase 1

TreatmentExperimental Group · 4 Interventions: Blood Draw, Carbon C 11 Glutamine, Fluorine F 18 L-glutamate Derivative BAY94-9392, Positron Emission Tomography · Intervention Types: Procedure, Biological, Biological, Procedure
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Blood Draw
2006
Completed Phase 2
~1480
Glutamic acid
FDA approved
Positron Emission Tomography
2008
Completed Phase 2
~2820

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 4 years after treatment

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,802 Previous Clinical Trials
1,788,869 Total Patients Enrolled
Lesley FlyntPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
tumor must have been sampled either at diagnosis or after treatment Cancer that has spread to other parts of the body and is confirmed by a pathologist to have a certain gene mutation (RAS wildtype) is considered Stage IV CRC
The patient is eligible for anti-EGFR monoclonal antibody therapy as standard-of-care, either as a single agent or in combination with approved SOC therapies or investigational agents as part of IRB-approved clinical trials.
tumor tissue must not be necrotic We need tumor tissue from the primary tumor to do RNA-seq gene analysis, but specimen from metastatic sites are not required but highly preferred.
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 is a measure of the size and extent of a tumor.
A patient will have a CT or MRI scan of their chest, abdomen, and pelvis as part of a standard-of-care procedure within 28 days of their baseline investigational 11C-Gln PET/CT scan
The lesion must be at least 2 cm in diameter in order to be measurable using PET Response Criteria in Solid Tumors (PERCIST) v1.0 to avoid PET partial volume effects.
To be able to provide written informed consent in accordance with institutional policies.
an adult You must be at least 18 years of age to be an adult.